Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 29
- Latest Decision
- 2021-03-09
Clearances · page 24 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202409 | Surgical Mask | Allmed Medical Products Co., Ltd. | FXX | Class II | 2021-03-09 |
| K210181 | Nordiwell Surgical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | FXX | Class II | 2021-03-09 |
| K203600 | VersaWrap | Alafair Biosciences, Inc. | FTM | Class II | 2021-03-09 |
| K202710 | Disposable Medical Face Mask | Wanxinda (Guangzhou) Technology Product Co., Ltd. | FXX | Class II | 2021-03-09 |
| K202205 | Surgical Face Mask | Jiangsu Micsafe Medical Technology Co., Ltd. | FXX | Class II | 2021-03-09 |
| K202439 | Disposable Medical Face Mask | Hunan Eexi Technology & Service Co., Ltd. | FXX | Class II | 2021-03-08 |
| K201974 | Single-use medical face mask | Guangdong Horigen Mother & Baby Products Co., Ltd. | FXX | Class II | 2021-03-07 |
| K203425 | Surgical Mask | Bdc Dental Corporation , Ltd. | FXX | Class II | 2021-03-05 |
| K203054 | FlexSys | Gme German Medical Engineering GmbH | GEX | Class II | 2021-03-05 |
| K210225 | Surgical Face Mask | Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. | FXX | Class II | 2021-03-04 |
| K202137 | Disposable medical mask | U-Play Products Corporation | FXX | Class II | 2021-03-04 |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | PZX | Class II | 2021-03-03 |
| K202316 | Medical mask (Model: KKF-1A) | Han Zhaoqing Sporting Goods Company Limited | FXX | Class II | 2021-03-03 |
| K203394 | PleuraFlow System with FlowGlide | Clearflow, Inc. | OTK | Class II | 2021-03-02 |
| K201852 | Surgical Mask-Model Number: Ear Loop, Flat-Pleated | Huizhou Foryou Medical Devices Co., Ltd. | FXX | Class II | 2021-03-02 |
| K202214 | IFM Surgical Mask Model SM3 | Fssc, LLC | FXX | Class II | 2021-03-02 |
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | NVK | Class II | 2021-02-26 |
| K203510 | IPL Hair removal | Shenzhen Weikai Technology Co.,Ltd | OHT | Class II | 2021-02-26 |
| K210033 | Laser Treatment System, Model: NYX and Grace | Canadian Pioneer Medical Technology Corporation | GEX | Class II | 2021-02-26 |
| K202702 | FLARE Single-Use Surgical Laser Fiber | Realton (Suzhou) Medical Technology Co., Ltd. | GEX | Class II | 2021-02-26 |
| DEN190022 | Hominis Surgical System | Momentis Surgical , Ltd. | QNM | Class II | 2021-02-26 |
| K202240 | Disposable Surgical Mask/Fluid Resistant Procedure Mask | Lhm Medical Technology (Hong Kong) Limited | FXX | Class II | 2021-02-25 |
| K203524 | Surgical Masks | Bain Medical Equipment (Guangzhou) Co., Ltd. | FXX | Class II | 2021-02-25 |
| K203665 | STOP U Model UXV Device | Pollogen, Ltd. | PAY | Class II | 2021-02-25 |
| K202988 | Tixel System | Novoxel , Ltd. | GEI | Class II | 2021-02-25 |
| K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | PBY | Class II | 2021-02-24 |
| K203804 | Global Med Systems Milesman Compact Laser | Global Med Systems SL | GEX | Class II | 2021-02-23 |
| K202950 | StitchKit COMBO | Origami Surgical | GAM | Class II | 2021-02-23 |
| K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | GEI | Class II | 2021-02-23 |
| K203522 | Surn5 Electrosurgical Argon Beam Generator and Accessories | Surnic Corporation | GEI | Class II | 2021-02-22 |
| K201868 | Phyziofit Medical Surgical Mask | Wellpower Sporting Goods Co., Ltd. | FXX | Class II | 2021-02-22 |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | PZL | Class II | 2021-02-21 |
| K201182 | iMask Disposable Surgical Face Mask | Pac-Dent, Inc. | FXX | Class II | 2021-02-19 |
| K201408 | Demetra Analytics Toolkit | Barco N.V. | PSN | Class II | 2021-02-18 |
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | Somatex Medical Technologies GmbH | NEU | Class II | 2021-02-18 |
| K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi Medical Technology Co., Ltd. | FXX | Class II | 2021-02-18 |
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein | Eco Medi Glove Sdn. Bhd. | KGO | Class I | 2021-02-17 |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On | Dukal Corporation | FXX | Class II | 2021-02-16 |
| K202341 | Disposable Surgical Mask | Shanghai Jianzhong Medical Packaging Co., Ltd. | FXX | Class II | 2021-02-12 |
| K201545 | Surgical Face Mask | Amphastar Nanjing Pharmaceuticals, Inc. | FXX | Class II | 2021-02-12 |
| K202605 | Standard Procedure Mask, Standard Surgical Mask | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | FXX | Class II | 2021-02-10 |
| K203265 | nPro Surgical Mask | Np Medical, Inc. | FXX | Class II | 2021-02-09 |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | M/s. Meril Endo Surgery Private Limited. | GDW | Class II | 2021-02-05 |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons | Dukal Corporation | FXX | Class II | 2021-02-05 |
| K210063 | Freudenberg Surgical Mask | Freudenberg Performance Materials LP | FXX | Class II | 2021-02-05 |
| K202493 | Medical Face Mask | Gemtier Medical (Shanghai), Inc. | FXX | Class II | 2021-02-04 |
| K202627 | Medical Face Masks | Guilin Hbm Sanitary Protections, Inc. | FXX | Class II | 2021-02-03 |
| K202331 | Medical Face Mask | Gemtier Medical (Shanghai), Inc. | FXX | Class II | 2021-02-02 |
| K202323 | Disposable Medical Surgical Masks | Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. | FXX | Class II | 2021-02-02 |
| K202096 | 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On | Ecoguard, Inc. | FXX | Class II | 2021-02-02 |
| K202511 | Disposable Medical Surgical Mask | Improve Medical (Hunan) Co., Ltd. | FXX | Class II | 2021-02-02 |
| K203299 | CellFX System | Pulse Biosciences, Inc. | GEI | Class II | 2021-02-02 |
| K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | KGO | Class I | 2021-02-01 |
| K203393 | FAST-FIX FLEX | Smith & Nephew, Inc. | GAT | Class II | 2021-02-01 |
| K202358 | Protective Face Mask for Medical Use | Hunan Heng Chang Pharmaceutical Co., Ltd. | FXX | Class II | 2021-01-29 |
| K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back | Wildcat Ppe, LLC | FYC | Class II | 2021-01-29 |
| K191878 | DEX Device | Dex Surgical | GEI | Class II | 2021-01-29 |
| K201801 | Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | 2021-01-29 |
| K190677 | EndoClot | Endoclot Plus Co., Ltd. | QAU | Class II | 2021-01-29 |
| K202199 | BTL-899ST | Btl | GEI | Class II | 2021-01-26 |
| K201066 | ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | Ethicon Endo-Surgery, LLC | GEI | Class II | 2021-01-22 |
| K202415 | VirtueRF | ShenB Co., Ltd. | GEI | Class II | 2021-01-22 |
| K202640 | Surgical Mask | Jiangsu Medpure Biological Technology Co., Ltd. | FXX | Class II | 2021-01-22 |
| K201696 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length | Ethicon Endo-Surgery, LLC | GEI | Class II | 2021-01-22 |
| K193266 | MIIN | Medico USA, Inc. | GEX | Class II | 2021-01-22 |
| K202507 | EEA Circular Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2021-01-21 |
| K202595 | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask | Premier Guard USA, LLC | FXX | Class II | 2021-01-21 |
| K202904 | Surgical Face Mask | Jiangxi Feilikang Medical Technology Co., Ltd. | FXX | Class II | 2021-01-21 |
| K201366 | Forwarts | Pronova Laboratories BV | GEH | Class II | 2021-01-21 |
| K201685 | Potenza | Jeisys Medical, Inc. | GEI | Class II | 2021-01-19 |
| K202107 | Medical Protective Mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | FXX | Class II | 2021-01-15 |
| K203241 | OmniGuide BeamPath OTO-U Fiber | Omniguide, Inc. | GEX | Class II | 2021-01-14 |
| K192933 | Polyisoprene Powder Free, Black Colour Surgical Gloves | Emerson & Co. Srl | KGO | Class I | 2021-01-13 |
| K202314 | Procedure face mask (Model: KKF-2A) | Han Zhaoqing Sporting Goods Company Limited | FXX | Class II | 2021-01-13 |
| K201625 | Disposable Medical Surgical Mask | Tianjin Saiyuan Technology Co., Ltd. | FXX | Class II | 2021-01-12 |
| K202843 | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | FXX | Class II | 2021-01-12 |
| K202577 | Medical Surgical Mask-Model MP002-5, MP002-6 | Jiangmen Sure&Me Medical Product Co., Ltd. | FXX | Class II | 2021-01-11 |
| K200918 | SurgiWrap FROST | Mast Biosurgery | FTL | Class II | 2021-01-07 |
| K203117 | TissueTak device | Via Surgical , Ltd. | GDW | Class II | 2021-01-07 |
| K202594 | Medical Surgical Masks-Non Sterile | Shandong T&F Nonwoven Co., Ltd. | FXX | Class II | 2021-01-06 |
| K202844 | Medical Surgical Gowns | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | FYA | Class II | 2021-01-06 |
| K202491 | Disposable Surgical Face Mask | Jiangsu Newvalue Medical Products Co., Ltd. | FXX | Class II | 2021-01-06 |
| K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | NEY | Class II | 2021-01-05 |
| K202880 | J-Plasma Precise FLEX Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation | GEI | Class II | 2021-01-04 |
| K202719 | Disposable Medical Face Masks | Jiangxi Sanxin Medtec Co., Ltd. | FXX | Class II | 2021-01-04 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | JCT | Class II | 2020-12-31 |
| K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | FXX | Class II | 2020-12-31 |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | FYA | Class II | 2020-12-31 |
| K201754 | JianYu Surgical Mask | Jiangsu Jianyu Health Medical Co., Ltd. | FXX | Class II | 2020-12-30 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. | GEX | Class II | 2020-12-24 |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corporation | PEM | Class II | 2020-12-23 |
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | FWP | Class II | 2020-12-23 |
| K202061 | Medical Face mask | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | FXX | Class II | 2020-12-23 |
| K202211 | Disposable Medical Surgical Face Masks | Guangdong Kaidi Garments Co.,Ltd | FXX | Class II | 2020-12-22 |
| K201996 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | GAM | Class II | 2020-12-21 |
| K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein | Medline Industries, Inc. | KGO | Class I | 2020-12-19 |
| K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | OLI | Class II | 2020-12-18 |
| K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | ArthroCare Corporation | GEI | Class II | 2020-12-18 |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Aesculap, Inc. | GEI | Class II | 2020-12-18 |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | Chemence Medical, Inc. | MPN | Class II | 2020-12-17 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.