Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 1993-10-29
Clearances · page 111 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K930450 | BUFFALO FILTER REPLACEMENT FILTER #BILF-100 | Buffalo Filter Co., Inc. | FYD | Class II | 1993-10-29 |
| K933327 | HISTOFREEZER | Solarcare, Inc. | GEH | Class II | 1993-10-29 |
| K931150 | GORE-TEX MICRO MESH | W. L. Gore & Associates, Inc. | FTL | Class II | 1993-10-29 |
| K933593 | LUMINOUS 150 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | HBI | Class II | 1993-10-28 |
| K930784 | THE DE SOUTTER M193 REAMER | De Soutter Medical, Ltd. | HSZ | Class I | 1993-10-27 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | GCY | Class I | 1993-10-27 |
| K934172 | ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS | Acro-Poly, Inc. | GEY | Class I | 1993-10-27 |
| K930785 | THE DE SOUTTER M182 DRILL | De Soutter Medical, Ltd. | HSZ | Class I | 1993-10-27 |
| K931776 | DIOMED 25 25W SURGICAL DIODE LASER | Dio-Med Corp. | GEX | Class II | 1993-10-19 |
| K933365 | BABISTICK | Graphic Controls Corp. | FMK | Class II | 1993-10-19 |
| K926297 | REFLEX ESI | Richard-Allan Medical Ind., Inc. | GEI | Class II | 1993-10-15 |
| K926203 | ENDOSCOPIC SCISSORS (DISPOSABLE/REUSABLE SHAFTS) | Weck Endoscopy | GEI | Class II | 1993-10-15 |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | O.R. Concepts, Inc. | GEI | Class II | 1993-10-15 |
| K933322 | ZEISS OPMILAS 144 SURGICAL LASERS | Carl Zeiss, Inc. | GEX | Class II | 1993-10-15 |
| K932156 | MULTILINE; DLY-1 | Derma-Lase Co. | GEX | Class II | 1993-10-15 |
| K932628 | ENDOSCOPIC VIDEO CAMERA | Stephen Chakoff, Inc. | FWF | Class I | 1993-10-15 |
| K931828 | CARELET SAFETY LANCET | Gainor Medical Europe, Ltd. | FMK | Class II | 1993-10-15 |
| K932421 | SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE | Surgilase, Inc. | GEX | Class II | 1993-10-15 |
| K932700 | CUTO(TM) TISSUE MORCELLATION SYSTEM | Linvatec Corp. | GEY | Class I | 1993-10-15 |
| K926525 | BETASTAR 1131.02 MOBILE OPERATING TABLE | Stierlen-Maquet AG | FQO | Class I | 1993-10-12 |
| K931103 | STRYKER STAPLER SYSTEM | Stryker Endoscopy | GDW | Class II | 1993-10-12 |
| K932272 | CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS | Lc Ent. | GEX | Class II | 1993-10-12 |
| K922442 | ISOLATION GOWNS | Pfb Inter-Apparel Corp. | FYC | Class II | 1993-10-12 |
| K926288 | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | Jedmed Instrument Co. | FSO | Class I | 1993-10-12 |
| K932518 | TECH-SWITCH ELECTROSURGICAL PENCIL, REUSABLE | Conmedcorp | GEI | Class II | 1993-10-12 |
| K925754 | ECONOM | Rudolf Riester GmbH & Co. KG | EPY | Class I | 1993-10-08 |
| K924720 | VISIDISC KITS, SPINESCOPE | Laserscope | GEX | Class II | 1993-10-08 |
| K932494 | PM PUMP ASPIRATOR | Precision Medical, Inc. | BTA | Class II | 1993-10-07 |
| K931070 | CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM | Lca, Inc. | GEX | Class II | 1993-10-05 |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | GCY | Class I | 1993-10-05 |
| K933306 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | GCY | Class I | 1993-10-05 |
| K931982 | NEW ENGLAND MEDICAL GROUNDING PAD | New England Medical, Inc. | GEI | Class II | 1993-10-05 |
| K931959 | JARIT SURGICAL INSTRUMENTS | J. Jamner Surgical Instruments, Inc. | GEI | Class II | 1993-10-05 |
| K930026 | POLY-MED DISPOSABLE PERSONAL PROTECTION KIT | Medtek Development Corp. | FYC | Class II | 1993-10-04 |
| K931481 | MINI-LANCET | Pacific Rim Products, Inc. | FMK | Class II | 1993-10-01 |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Coherent Medical Group | GEX | Class II | 1993-09-29 |
| K925647 | VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE | Valleylab, Inc. | GEI | Class II | 1993-09-29 |
| K932785 | MONOJECT(R) MONOLETTOR SAFETY LANCET | Sherwood Medical Co. | FMK | Class II | 1993-09-29 |
| K932220 | LAP CHOLY TRAYS (PACKS) | Associated Medical Products Co. | LRO | Class II | 1993-09-27 |
| K931978 | SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM | Sharplan Lasers, Inc. | GEX | Class II | 1993-09-23 |
| K926103 | POLYP SNARE NET W/MONOPOLAR CAUTERY | United States Endoscopy Group, Inc. | GEI | Class II | 1993-09-23 |
| K933333 | HGM SCANMAN PLUS | Hgm, Inc. | GEX | Class II | 1993-09-23 |
| K933332 | MODEL 6400 ABC ELECTROSURGERY GENERATOR | William E. Mckay | GEI | Class II | 1993-09-23 |
| K931212 | DIOMED 25 25W SURGICAL DIODE LASER | Dio-Med Corp. | GEX | Class II | 1993-09-23 |
| K932102 | ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | GEI | Class II | 1993-09-23 |
| K933146 | ESB 2400 SEI | Esb, Inc., Div. of Ray-O-Vac | FTC | Class II | 1993-09-23 |
| K932468 | NOVUS MULTIWAVELENGTH | Coherent Medical Group | GEX | Class II | 1993-09-22 |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | GCY | Class I | 1993-09-16 |
| K914519 | DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC | Dio-Med Corp. | GEX | Class II | 1993-09-16 |
| K925642 | ZEISS DIODE-PUMPED SOLID STATE LASER | Carl Zeiss, Inc. | GEX | Class II | 1993-09-13 |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Gainor Medical Europe, Ltd. | FMK | Class II | 1993-09-13 |
| K924731 | PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | FYD | Class II | 1993-09-13 |
| K924732 | PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | FYD | Class II | 1993-09-13 |
| K932857 | ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC. | Ansley Medical Products, Inc. | KKX | Class II | 1993-09-13 |
| K926565 | GORE-TEX(TM) DUAL MESH | W. L. Gore & Associates, Inc. | FTL | Class II | 1993-09-09 |
| K931885 | DRIGEL MULTIFUNCTION ELECTRODE | Physiometrix, Inc. | GEI | Class II | 1993-09-09 |
| K931876 | FISK ARM SUPPORT | Vvortex International Corp. | FWW | Class I | 1993-09-09 |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | Elekta Instruments, Inc. | GEY | Class I | 1993-09-07 |
| K931537 | A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT | Alto Development Corp. | GEI | Class II | 1993-09-07 |
| K924335 | DRAPES | Pfb Inter-Apparel Corp. | KKX | Class II | 1993-09-07 |
| K932720 | HM-0970 | Hill-Med, Inc. | HRM | Class I | 1993-09-07 |
| K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT | Polyclinic Medical Center | KKY | Class II | 1993-09-02 |
| K931198 | UNIQUET | Icat Systems | GAX | Class I | 1993-09-01 |
| K930409 | PMT(R) SILICONE GEL SHEETING MODEL 3505-1 | Pmt Corp. | MDA | Class I | 1993-09-01 |
| K926269 | PROCEDURE KIT | General Medical Co. | LRO | Class II | 1993-08-27 |
| K924055 | N-PAC | National Healthcare Linen Service | FYA | Class II | 1993-08-27 |
| K930856 | PSORALITE | Daavlin Co. | FTC | Class II | 1993-08-26 |
| K931101 | ECLIPSE 2100(TM) MODEL 32, MODIFICATION | Cardiogenes | GEX | Class II | 1993-08-25 |
| K931492 | LAPRA-TY* SUTURE CLIP | ETHICON, Inc. | FZP | Class II | 1993-08-24 |
| K926464 | L.C.S.3000 | Cryodyne Technologies, Inc. | GEH | Class II | 1993-08-24 |
| K930975 | DERMA-LASE DLA-1 LASER | Derma-Lase Co. | GEX | Class II | 1993-08-19 |
| K930793 | MULTILINE; DLY-1 | Derma-Lase Co. | GEX | Class II | 1993-08-19 |
| K931499 | Q-11 OPHTHALMIC LASER | Hgm, Inc. | GEX | Class II | 1993-08-19 |
| K933310 | MICRINS CONTRAST BACKGROUND MATERIAL | Micrins Surgical, Inc. | EPT | Class I | 1993-08-19 |
| K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | Innovative Surgical, Inc. | GFI | Class I | 1993-08-19 |
| K926438 | ACTION MEDTEK FACE SHIELD | Action Eyewear Corp. | LYU | Class I | 1993-08-18 |
| K932998 | EASY-ON | Devon Industries, Inc. | GES | Class I | 1993-08-18 |
| K925077 | POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS | Medtek Development Corp. | FYC | Class II | 1993-08-16 |
| K926519 | SURGICAL GOWN | Custom Medical Products, Ltd. | FYA | Class II | 1993-08-12 |
| K931299 | HISTOFREEZER | Solarcare Technologies Corp,Inc. | GEH | Class II | 1993-08-11 |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | GCY | Class I | 1993-08-11 |
| K925117 | URESIL ABSCESS DRIANAGE AND IRRIGATION SET | Uresil Corp. | GBX | Class I | 1993-08-11 |
| K925743 | NASAL DORSUM | Smith & Nephew Richards, Inc. | FZE | Class II | 1993-08-10 |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | GCY | Class I | 1993-08-10 |
| K932228 | MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER | Boston Scientific Corp | GBZ | Class I | 1993-08-10 |
| K933298 | SAW BLADE | Omega Surgical Instruments, Inc. | GFA | Class I | 1993-08-09 |
| K932385 | SUTURE REMOVING FORCEPS | Rocket of London, Ltd. | GEN | Class I | 1993-08-06 |
| K931607 | MEDDRAINS | Armm, Inc. | GBN | Class I | 1993-08-06 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | GAD | Class I | 1993-08-06 |
| K920865 | SHARPLAN 2100,3000,SHARPLASER 65, 40 | Sharplan Lasers, Inc. | GEX | Class II | 1993-08-02 |
| K930686 | MIDMARK SURGICAL LIGHTING SYSTEMS | Midmark Corp. | FSQ | Class II | 1993-07-30 |
| K930711 | TRI*STAR | Light Technology Systems | FSS | Class II | 1993-07-30 |
| K932139 | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT | Aaron Medical Industries | FSQ | Class II | 1993-07-30 |
| K931037 | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | Whitmore Ent., Inc. | FWZ | Class I | 1993-07-30 |
| K926210 | ECLIPSE 3200 | Cardiogenes | GEX | Class II | 1993-07-28 |
| K930981 | ACCULITE(TM) OTOPROBE | Coherent Medical Group | GEX | Class II | 1993-07-28 |
| K930099 | LASER HANDPIECE SHROUD | I.C Medical, Inc. | GEX | Class II | 1993-07-28 |
| K930097 | ELECTROCAUTERY SHROUD | I.C Medical, Inc. | GEI | Class II | 1993-07-28 |
| K930098 | SPECULUM SMOKE EVACUATOR TUBING | I.C Medical, Inc. | GEX | Class II | 1993-07-28 |
| K931028 | VALLEYLAB RETRACTABLE ELECTRODES | Valleylab, Inc. | GEI | Class II | 1993-07-27 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.