FDA Product Code
FDA Product Code GCJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 1,430 records · page 1 of 15
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262397 | CuratOR EX2742 | Eizo Corporation | 2026-09-11 | Traditional | PDF ↗ |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026-09-01 | Traditional | PDF ↗ |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | 2026-08-26 | Traditional | PDF ↗ |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | 2026-08-13 | Traditional | PDF ↗ |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | 2026-07-24 | Traditional | PDF ↗ |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 | Traditional | PDF ↗ |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 | Traditional | PDF ↗ |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | 2026-06-11 | Traditional | PDF ↗ |
| K260414 | Tech-Image Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 | Traditional | PDF ↗ |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 | Traditional | PDF ↗ |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 | Traditional | PDF ↗ |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 | Traditional | PDF ↗ |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 | Traditional | PDF ↗ |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 | Traditional | PDF ↗ |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 | Traditional | PDF ↗ |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 | Traditional | PDF ↗ |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 | Traditional | PDF ↗ |
| K260197 | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 | Traditional | PDF ↗ |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 | Traditional | PDF ↗ |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-02-24 | Traditional | PDF ↗ |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2026-02-18 | Special | PDF ↗ |
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | 2026-02-12 | Special | PDF ↗ |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 | Traditional | PDF ↗ |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 2026-01-23 | Traditional | PDF ↗ |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2026-01-13 | Special | PDF ↗ |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 | Traditional | PDF ↗ |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025-11-20 | Traditional | PDF ↗ |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp. | 2025-10-31 | Traditional | PDF ↗ |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | 2025-10-29 | Traditional | PDF ↗ |
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | 2025-10-20 | Traditional | PDF ↗ |
| K251994 | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | 2025-10-16 | Traditional | PDF ↗ |
| K243968 | Revolve Surgical System | Revolve Surgical, Inc. | 2025-10-03 | Traditional | PDF ↗ |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | 2025-10-02 | Traditional | PDF ↗ |
| K251743 | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | 2025-09-22 | Traditional | PDF ↗ |
| K250130 | Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 | Traditional | PDF ↗ |
| K250124 | Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 | Traditional | PDF ↗ |
| K252010 | SPY Laparoscope | Stryker Endoscopy | 2025-07-24 | Special | PDF ↗ |
| K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. | 2025-07-02 | Traditional | PDF ↗ |
| K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | 2025-07-02 | Traditional | PDF ↗ |
| K251209 | Medical Monitor (32HS710S) | Lg Electronics.Inc | 2025-06-12 | Traditional | PDF ↗ |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2025-05-05 | Traditional | PDF ↗ |
| K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025-03-17 | Traditional | PDF ↗ |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik, LLC | 2025-03-12 | Traditional | PDF ↗ |
| K243439 | Medical Monitor (27HS714S) | Lg Electronics.Inc | 2025-01-28 | Traditional | PDF ↗ |
| K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025-01-22 | Traditional | PDF ↗ |
| K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | 2024-12-13 | Traditional | PDF ↗ |
| K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | 2024-11-22 | Traditional | PDF ↗ |
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2024-11-06 | Special | PDF ↗ |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) | Lagis Enterprise Co., Ltd. | 2024-10-30 | Traditional | PDF ↗ |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | Guangdong Optomedic Technologies, Inc. | 2024-10-23 | Traditional | PDF ↗ |
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | 2024-10-04 | Traditional | PDF ↗ |
| K241052 | Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH | 2024-10-04 | Traditional | PDF ↗ |
| K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | 2024-08-28 | Traditional | PDF ↗ |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2024-08-15 | Traditional | PDF ↗ |
| K241402 | Medical Monitor (32HR734S) | Lg Electronics.Inc | 2024-08-12 | Traditional | PDF ↗ |
| K241530 | Stellar Imaging System | Guangdong Optomedic Technologies, Inc. | 2024-08-07 | Traditional | PDF ↗ |
| K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2024-08-05 | Traditional | PDF ↗ |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024-07-25 | Traditional | PDF ↗ |
| K241502 | P-SCOPE | Oui Medical, Inc. | 2024-07-24 | Traditional | PDF ↗ |
| K241739 | Endoscopic Applicator, 41 cm | Micromedics, Inc. | 2024-07-15 | Special | PDF ↗ |
| K241111 | AMT Suture Passer | Applied Medical Technology, Inc. | 2024-07-05 | Traditional | PDF ↗ |
| K233840 | Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024-06-26 | Traditional | PDF ↗ |
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | Schoelly Fiberoptic GmbH | 2024-06-20 | Traditional | PDF ↗ |
| K240196 | Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) | Yuwonmeditech Co., Ltd. | 2024-06-18 | Traditional | PDF ↗ |
| K233892 | 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024-06-13 | Traditional | PDF ↗ |
| K233386 | Monik - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. | 2024-05-24 | Traditional | PDF ↗ |
| K240205 | Ez Catch Auto; Ez Catch YR; Ez Catch TR | Veol Medical Technologies Pvt , Ltd. | 2024-04-15 | Traditional | PDF ↗ |
| K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024-04-09 | Traditional | PDF ↗ |
| K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm | Ximedica | 2024-04-01 | Special | PDF ↗ |
| K240174 | 1688 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2024-02-22 | Special | PDF ↗ |
| K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K222783 | MD Mattress Suture Placement Device | Lsi Solutions, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K233327 | 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2024-01-09 | Special | PDF ↗ |
| K232519 | ENDOCOLLECT Specimen Retrieval Bag | Ximedica | 2024-01-05 | Traditional | PDF ↗ |
| K231066 | CuratOR EX3242-FD | Eizo Corporation | 2023-12-18 | Traditional | PDF ↗ |
| K232866 | Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) | Jiangsu Channel Medical Device Co., Ltd. | 2023-11-07 | Traditional | PDF ↗ |
| K232880 | Inzii Ripstop Redeployable Retrieval System | Applied Medical Resources Corporation | 2023-11-01 | Special | PDF ↗ |
| K232042 | NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021); | Mediconcepts Technology (Shenzhen) Company Limited | 2023-10-20 | Traditional | PDF ↗ |
| K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | Hunan Endoso Life Technology Co., Ltd. | 2023-10-16 | Traditional | PDF ↗ |
| K232701 | Guardenia (GAR-1) | Advanced Surgical Concepts | 2023-09-29 | Special | PDF ↗ |
| K231622 | REGER Nebulizer Irrigation Cannula | Reger Medizintechnik, GmbH | 2023-09-29 | Traditional | PDF ↗ |
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Corporation | 2023-08-18 | Special | PDF ↗ |
| K231400 | Bladeless Trocar Artemis Lap Cannula | T.A.G. Medical Products Corporation, Ltd. | 2023-08-04 | Special | PDF ↗ |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | Guangdong Optomedic Technologies, Inc. | 2023-07-06 | Traditional | PDF ↗ |
| K231358 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2023-07-05 | Traditional | PDF ↗ |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | Karl Storz Endoscopy America, Inc. | 2023-06-23 | Traditional | PDF ↗ |
| K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2023-06-21 | Special | PDF ↗ |
| K231042 | Disposable Laparoscopic Trocar | Changzhou Ankang Medical Instruments Co., Ltd. | 2023-06-08 | Traditional | PDF ↗ |
| K223718 | HandX Self-Righting Needle Holder | Human Xtensions , Ltd. | 2023-06-05 | Traditional | PDF ↗ |
| K223562 | Xpan Universal Trocar System | Xpan, Inc. | 2023-06-02 | Traditional | PDF ↗ |
| K230491 | HandX Monopolar Scissors | Human Xtensions , Ltd. | 2023-05-10 | Traditional | PDF ↗ |
| K230058 | Bladeless Trocar Artemis Lap Cannula | T.A.G. Medical Products Corporation, Ltd. | 2023-04-28 | Traditional | PDF ↗ |
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | Stryker | 2023-03-31 | Special | PDF ↗ |
| K223923 | HOPKINS Telescopes | KARL STORZ Endoscopy-America, Inc. | 2023-03-30 | Traditional | PDF ↗ |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | Taiwan Surgical Corporation | 2023-03-22 | Traditional | PDF ↗ |
| K222828 | Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2023-03-20 | Traditional | PDF ↗ |
| K223116 | 8X-10-6XXX Camera Head | Santa Barbara Imaging Systems | 2023-02-28 | Traditional | PDF ↗ |
| K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023-02-24 | Traditional | PDF ↗ |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | Schoelly Fiberoptic GmbH | 2023-02-23 | Traditional | PDF ↗ |
Product code GCJ · Class II · Gastroenterology, Urology. Data: openFDA.