FDA Product Code
FDA Product Code GEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 2,319 records · page 1 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | 2026-09-17 | Special | PDF ↗ |
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | 2026-09-17 | Traditional | PDF ↗ |
| K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | 2026-09-15 | Traditional | PDF ↗ |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | 2026-09-11 | Traditional | PDF ↗ |
| K262364 | Ellian Enigma RF Device | Ellian Corp | 2026-09-02 | Traditional | PDF ↗ |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | 2026-08-27 | Traditional | PDF ↗ |
| K252535 | Inno-Switch Laparoscopic Instruments | Taiwan Surgical Corporation | 2026-08-25 | Traditional | PDF ↗ |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 | Traditional | PDF ↗ |
| K253504 | Volnewmer | Classys, Inc. | 2026-07-13 | Traditional | PDF ↗ |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | 2026-07-01 | Traditional | PDF ↗ |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 | Traditional | PDF ↗ |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 | Traditional | PDF ↗ |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 | Traditional | PDF ↗ |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 | Traditional | PDF ↗ |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 | Special | PDF ↗ |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 | Traditional | PDF ↗ |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 | Traditional | PDF ↗ |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 | Traditional | PDF ↗ |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 | Traditional | PDF ↗ |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 | Special | PDF ↗ |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 | Traditional | PDF ↗ |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 | Traditional | PDF ↗ |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 | Traditional | PDF ↗ |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 | Traditional | PDF ↗ |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 | Traditional | PDF ↗ |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 | Traditional | PDF ↗ |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 | Traditional | PDF ↗ |
| K253405 | Prana System | Prana Surgical | 2026-04-01 | Traditional | PDF ↗ |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 | Traditional | PDF ↗ |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 | Traditional | PDF ↗ |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 | Traditional | PDF ↗ |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 | Traditional | PDF ↗ |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | 2026-03-02 | Traditional | PDF ↗ |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026-02-24 | Special | PDF ↗ |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | 2026-02-11 | Traditional | PDF ↗ |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 | Traditional | PDF ↗ |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | 2026-01-30 | Special | PDF ↗ |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026-01-27 | Special | PDF ↗ |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 2026-01-27 | Traditional | PDF ↗ |
| K251254 | Ignite RF System | InMode , Ltd. | 2026-01-15 | Traditional | PDF ↗ |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | 2026-01-14 | Traditional | PDF ↗ |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | 2026-01-12 | Traditional | PDF ↗ |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | 2025-12-18 | Traditional | PDF ↗ |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC | 2025-11-24 | Traditional | PDF ↗ |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 2025-11-17 | Traditional | PDF ↗ |
| K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025-11-06 | Traditional | PDF ↗ |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | 2025-11-04 | Special | PDF ↗ |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation | 2025-10-31 | Traditional | PDF ↗ |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. | 2025-10-28 | Traditional | PDF ↗ |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | 2025-10-21 | Traditional | PDF ↗ |
| K250852 | Coolfase | Asterasys Co., Ltd. | 2025-10-16 | Traditional | PDF ↗ |
| K252367 | InbellaMulti System | Inbella Medical, Inc. | 2025-10-15 | Traditional | PDF ↗ |
| K250688 | Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) | Acotec Scientific Co., Ltd. | 2025-10-07 | Traditional | PDF ↗ |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | Olympus Medical Systems Corporation | 2025-10-07 | Traditional | PDF ↗ |
| K251899 | E Blator | New Deantronics Taiwan , Ltd. | 2025-10-01 | Traditional | PDF ↗ |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | 2025-09-29 | Traditional | PDF ↗ |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH | 2025-09-23 | Traditional | PDF ↗ |
| K252576 | Legend X Platform | Pollogen, Ltd. | 2025-09-12 | Special | PDF ↗ |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2025-09-09 | Traditional | PDF ↗ |
| K250217 | AGNES Ultra | Agnes Medical Co., Ltd. | 2025-09-03 | Traditional | PDF ↗ |
| K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025-08-29 | Traditional | PDF ↗ |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | Agnes Medical Co., Ltd. | 2025-08-19 | Traditional | PDF ↗ |
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | Venclose, Inc. | 2025-08-19 | Special | PDF ↗ |
| K252083 | HOTWIRE System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. | 2025-08-12 | Traditional | PDF ↗ |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | Cnc Technologies | 2025-08-11 | Special | PDF ↗ |
| K251327 | XERF | Lutronic Corporation | 2025-08-11 | Traditional | PDF ↗ |
| K252215 | InbellaMAX System | Inbella Medical , Ltd. | 2025-07-25 | Special | PDF ↗ |
| K250065 | DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated | 2025-07-08 | Traditional | PDF ↗ |
| K243120 | HybridAPC probe | Erbe Elektromedizin GmbH | 2025-06-20 | Traditional | PDF ↗ |
| K251235 | Electrosurgical Pads | Baisheng Medical Co., Ltd. | 2025-06-19 | Traditional | PDF ↗ |
| K242996 | EndyMed PRO MAX | Endymed Medical, Ltd. | 2025-06-10 | Traditional | PDF ↗ |
| K242907 | DELPHI System | CnS Medical Co., Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K250657 | gi2000 Electrosurgical Generator | Cintron Medical Corporation | 2025-06-03 | Traditional | PDF ↗ |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) | Maquet Cardiovascular, LLC | 2025-05-30 | Traditional | PDF ↗ |
| K250048 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2025-05-29 | Traditional | PDF ↗ |
| K243176 | BLESSING System | Cellah Medical Co., Ltd. | 2025-05-16 | Traditional | PDF ↗ |
| K240857 | Youmagic FLM System (YM5-U1) | We Medical Technology (Wuxi) Co., Ltd. | 2025-05-15 | Traditional | PDF ↗ |
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | 2025-05-09 | Traditional | PDF ↗ |
| K242469 | RFMagik Lite | Agnes Medical Co., Ltd. | 2025-04-25 | Traditional | PDF ↗ |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | Stryker Instruments | 2025-04-15 | Special | PDF ↗ |
| K242773 | Electro Lube NXT | Steris | 2025-04-15 | Traditional | PDF ↗ |
| K243451 | FiAPC plus probes | Erbe Elektromedizin GmbH | 2025-03-21 | Traditional | PDF ↗ |
| K242241 | Sunny | ShenB Co., Ltd. | 2025-03-19 | Traditional | PDF ↗ |
| K243918 | Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC | 2025-02-26 | Traditional | PDF ↗ |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | Boston Aesthetics, Inc. | 2025-02-13 | Traditional | PDF ↗ |
| K250200 | InbellaBody System | Inbella Medical, Inc. | 2025-02-11 | Special | PDF ↗ |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. | 2025-02-05 | Special | PDF ↗ |
| K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | 2025-02-04 | Special | PDF ↗ |
| K240311 | JETT Medical II | Compex, Spol, S.R.O. | 2025-01-22 | Traditional | PDF ↗ |
| K243139 | Reverso Pro System | Indiba S. A. U. | 2025-01-22 | Traditional | PDF ↗ |
| K243929 | Oligio X | Wontech Co., Ltd. | 2025-01-21 | Special | PDF ↗ |
| K243067 | The ETHICON Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025-01-17 | Traditional | PDF ↗ |
| K233118 | DUET-V (Model: ESK-3261DV) | Eunsung Global Corp | 2025-01-03 | Traditional | PDF ↗ |
| K243737 | Inbella RF System | Inbella Medical, Inc. | 2025-01-03 | Traditional | PDF ↗ |
| K243097 | RM STAR EX with RMS Needle | Bomtech Electronics Co., Ltd. | 2024-12-26 | Traditional | PDF ↗ |
| K240975 | Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) | Beijing Taktvoll Technology Co., Ltd. | 2024-12-23 | Traditional | PDF ↗ |
| K242688 | Finiff System | Skingrab Co., Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | Medline Industries, LP | 2024-12-19 | Traditional | PDF ↗ |
| K240758 | Radiofrequency Generator System, Cura RF Electrode | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-12-11 | Traditional | PDF ↗ |
| K242630 | Aerin Console | Aerin Medical, Inc. | 2024-12-10 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.