Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 48
- Latest Decision
- 2026-05-22
Clearances · page 2 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253569 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | NYV | Class II | 2026-05-22 |
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | NAY | Class II | 2026-05-22 |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | PKL | Class II | 2026-05-21 |
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | KNS | Class II | 2026-05-21 |
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | Olympus Winter & Ibe GmbH | FAJ | Class II | 2026-05-21 |
| K252985 | Laport | Sejong Medical Co., Ltd. | GCJ | Class II | 2026-05-19 |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated | EZD | Class II | 2026-05-18 |
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | FJK | Class II | 2026-05-15 |
| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2026-05-15 |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | Hunan Accurate Bio-Medical Technology Co., Ltd. | KPI | Class II | 2026-05-14 |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | KNW | Class II | 2026-05-12 |
| K254192 | Senhance Ultrasonic System | Asensus Surgical | NAY | Class II | 2026-05-12 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | GCJ | Class II | 2026-05-11 |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | Verathon Medical (Canada) Ulc | FAJ | Class II | 2026-05-11 |
| K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. | GCA | Class II | 2026-05-08 |
| K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | NEZ | Class II | 2026-05-08 |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | Shenzhen Changkun Technology Co., Ltd. | KPI | Class II | 2026-05-06 |
| K260314 | Ancora-SB | Aspero Medical, Inc. | FDA | Class II | 2026-05-01 |
| DEN250023 | Aurie System | Cathbuddy, Inc. | SHV | Class II | 2026-04-30 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | GCJ | Class II | 2026-04-30 |
| K261086 | Break Wave | Sonomotion, Inc. | LNS | Class II | 2026-04-29 |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | Dolanvy (Suzhou) Medical Technology Co., Ltd. | KPI | Class II | 2026-04-28 |
| K260999 | LoFric Elle Pro | Wellspect AB | EZD | Class II | 2026-04-24 |
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | SHU | Class II | 2026-04-24 |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | FGE | Class II | 2026-04-24 |
| K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | FDS | Class II | 2026-04-21 |
| K242163 | SmartSurgN Visualization System | SmartsurgN, Inc. | OWN | Class II | 2026-04-20 |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | KPI | Class II | 2026-04-17 |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA | FAJ | Class II | 2026-04-16 |
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. | EXQ | Class II | 2026-04-16 |
| K251658 | Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | FGE | Class II | 2026-04-16 |
| K260965 | CVAC Aspiration System | Calyxo, Inc. | FED | Class II | 2026-04-13 |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Anhui Happiness Workshop Instruments Co., Ltd. | FGB | Class II | 2026-04-09 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | GCJ | Class II | 2026-04-08 |
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2026-04-08 |
| K260197 | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | GCJ | Class II | 2026-04-08 |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health PTE., Ltd. | PNR | Class II | 2026-04-08 |
| K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | FAJ | Class II | 2026-04-07 |
| K252809 | in2 Smart (in2S) | Virility Medical , Ltd. | QRC | Class II | 2026-04-06 |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. | FED | Class II | 2026-04-06 |
| K254153 | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | FBN | Class II | 2026-04-03 |
| K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | LQR | Class II | 2026-04-03 |
| K260724 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | QNP | Class II | 2026-04-03 |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited | EZD | Class II | 2026-04-01 |
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | FBK | Class II | 2026-03-31 |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. | FAJ | Class II | 2026-03-27 |
| K252926 | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | Restore Robotics | QSM | Class II | 2026-03-26 |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | PIF | Class II | 2026-03-20 |
| K260533 | ELISIO-H | Nipro Medical Corporation | KDI | Class II | 2026-03-19 |
| K253139 | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | FBN | Class II | 2026-03-19 |
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212) | Serim Research | FKJ | Class II | 2026-03-17 |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | FGE | Class II | 2026-03-13 |
| K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | PCU | Class II | 2026-03-13 |
| K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | QZF | Class II | 2026-03-12 |
| K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | EZD | Class II | 2026-03-12 |
| K253734 | Taurus Clip | Taurus Endoscopy | PKL | Class II | 2026-03-12 |
| K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | QKA | Class II | 2026-03-12 |
| K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | NAY | Class II | 2026-03-11 |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation | FDT | Class II | 2026-03-09 |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FGE | Class II | 2026-03-06 |
| K260013 | CVAC Image Processor | Calyxo, Inc. | FGB | Class II | 2026-03-06 |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | KGE | Class II | 2026-03-06 |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. | KNW | Class II | 2026-03-04 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | GCJ | Class II | 2026-02-27 |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | OWN | Class II | 2026-02-26 |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | 2026-02-24 |
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | KOD | Class II | 2026-02-23 |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc. | KNW | Class II | 2026-02-23 |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | FDT | Class II | 2026-02-22 |
| K251692 | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | FDI | Class II | 2026-02-21 |
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FAD | Class II | 2026-02-20 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | GCJ | Class II | 2026-02-18 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | FDS | Class II | 2026-02-17 |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | OWN | Class II | 2026-02-13 |
| K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | OCW | Class II | 2026-02-13 |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. | KPI | Class II | 2026-02-12 |
| K260108 | L12 LED Light Source with AIM | Stryker Endoscopy | OWN | Class II | 2026-02-12 |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | OWN | Class II | 2026-02-12 |
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | GCJ | Class II | 2026-02-12 |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2026-02-10 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | FDS | Class II | 2026-02-06 |
| K254305 | BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. | KDN | Class II | 2026-01-30 |
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | FDF | Class II | 2026-01-30 |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | GCJ | Class II | 2026-01-29 |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2026-01-29 |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare | EZD | Class II | 2026-01-29 |
| K253842 | Vena MicroAngioscope System | Vena Medical Holdings Corp | LYK | Class II | 2026-01-28 |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | KDI | Class II | 2026-01-26 |
| K253285 | Elitone for Men | Elidah, Inc. | QAJ | Class II | 2026-01-23 |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | GCJ | Class II | 2026-01-23 |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. | FBN | Class II | 2026-01-20 |
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | EZL | Class II | 2026-01-20 |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | NAY | Class II | 2026-01-16 |
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | FJK | Class II | 2026-01-16 |
| K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | 2026-01-16 |
| DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. | SGY | Class II | 2026-01-15 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | GCJ | Class II | 2026-01-13 |
| K252913 | Break Wave | Sonomotion, Inc. | LNS | Class II | 2026-01-12 |
| K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | EZD | Class II | 2026-01-02 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | FGE | Class II | 2025-12-29 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.