Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 45
- Latest Decision
- 1977-03-07
Clearances · page 163 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K770258 | CAP, CLARION NURSES, STYLE BOUFFANT 21 | Sherwood Medical Industries | FYF | Class I | 1977-03-07 |
| K770259 | CAP, CLARION SURGEON'S | Sherwood Medical Industries | FYF | Class I | 1977-03-07 |
| K770261 | HOOD, CLARION SURGEONS | Sherwood Medical Industries | FXY | Class II | 1977-03-01 |
| K761187 | HOUVA-LITE LEG UNIT #701 | National Biological Corp. | FTC | Class II | 1977-02-28 |
| K761189 | HOUVA-LITE SOLE UNIT #502 | National Biological Corp. | FTC | Class II | 1977-02-28 |
| K761188 | HOUVA-LITE PALM UNIT #501 | National Biological Corp. | FTC | Class II | 1977-02-28 |
| K761199 | AIRWAY PRESSURE MONITOR | Draeger Medical, Inc. | GAP | Class II | 1977-02-28 |
| K770154 | 3-WAY STOPCOCK WITH LUER-LOCK FITTING | American Viggo | KGZ | Class I | 1977-02-28 |
| K761186 | HOUVA-LITE ARM UNIT #601 | National Biological Corp. | FTC | Class II | 1977-02-28 |
| K770149 | MAJOR SUTURE REMOVAL TRAY | Pharmaseal Div., Baxter Healthcare Corp. | KDD | Class I | 1977-02-25 |
| K770257 | HOOD & BEARD COVER, CLARION SURGEON'S | Sherwood Medical Industries | FXY | Class II | 1977-02-25 |
| K770056 | GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE | Arbrook Mfg. Corp. | KGO | Class I | 1977-02-25 |
| K761334 | MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT | J. Sklar Mfg. Co., Inc. | GEN | Class I | 1977-02-24 |
| K770084 | OPERATING ROOM VENTILATOR | Dupaco, Inc. | FZH | Class II | 1977-02-23 |
| K770186 | ELECTRONIC DEPILATORY MODEL 202 | Electronic Depilatory, Inc. | KCX | Class I | 1977-02-23 |
| K770187 | ELECTRONIC DEPILATORY MODEL 303 | Electronic Depilatory, Inc. | KCX | Class I | 1977-02-23 |
| K770058 | PROBE, VACUUM INSULATED, SERIES 30 | Spembly Medical , Ltd. | GEH | Class II | 1977-02-17 |
| K770206 | GRASPING FORCEPS | Depuy, Inc. | HTD | Class I | 1977-02-08 |
| K770175 | SEA-BOND ADHEVISE DENTURE CUSHIONS | Combe, Inc. | KKX | Class II | 1977-02-04 |
| K761080 | ISOLATION GOWN PACK | American Hospital Supply Corp. | FYC | Class II | 1977-01-28 |
| K761018 | SURGICAL LIGHT - CHALLENGE 22 SERIES | Amsco Co. | FQP | Class II | 1977-01-26 |
| K770118 | CARPENTER BONE CLAMP | Stryker Corp. | HXD | Class I | 1977-01-26 |
| K761231 | MODEL 738 BIRT-A-PAD | Birtcher Corp. | GEI | Class II | 1977-01-14 |
| K761323 | SURGICAL MARKING PEN | Richard-Allan Medical Ind., Inc. | FZZ | Class I | 1977-01-12 |
| K761204 | BARRIER IMPERVIOUS BACK TABLE COVER | Surgikos, Inc. | KKX | Class II | 1977-01-12 |
| K761221 | NON-STERILE PREGELLED GROUNDING PAD | Ipco Corp. | GEI | Class II | 1977-01-12 |
| K761193 | SUTURE REMOVAL KIT | Superior Plastic Products Corp. | KDD | Class I | 1977-01-12 |
| K761093 | BANDAGE | Paco Pharmaceutical Services, Inc. | NAD | Class I | 1977-01-06 |
| K761322 | SURGICAL BLADES | Richard-Allan Medical Ind., Inc. | GES | Class I | 1977-01-06 |
| K761142 | HEADLIGHTS W/ FILTER-OPTICO CABLES | Pilling Co. | FST | Class II | 1977-01-05 |
| K761049 | KENATRON EPILATOR | Epilator Corp. | KCX | Class I | 1977-01-05 |
| K761070 | P.S.M. SURGICAL HOOD | The Owenby Co. | FXY | Class II | 1976-12-30 |
| K761064 | COVENTRY STAPLE | Depuy, Inc. | GDW | Class II | 1976-12-30 |
| K760904 | CLEANING AND ISOLATION ROOM KIT | American Hospital Supply Corp. | FYC | Class II | 1976-12-30 |
| K761071 | P.S.M. JUSTA KAP | The Owenby Co. | FYF | Class I | 1976-12-30 |
| K761068 | P.S.M. BOUFFANT CAP | The Owenby Co. | FYF | Class I | 1976-12-30 |
| K761069 | P.S.M. BOTIQUE CAP | The Owenby Co. | FYF | Class I | 1976-12-30 |
| K760898 | GOLDFARB LIVER CLAMP | Edward Weck, Inc. | GDJ | Class I | 1976-12-29 |
| K760675 | ELECTROSURGICAL DISPERSIVE PLATE | Aspen Laboratories, Inc. | GEI | Class II | 1976-12-28 |
| K760937 | BARRIER NEURO SHEET | Surgikos, Inc. | KKX | Class II | 1976-12-21 |
| K761035 | SURGICAL BLADE HANDLES | Parke-Davis Co. | GDZ | Class I | 1976-12-21 |
| K760696 | REMOTE CONTROL SYSTEM FOR MICROSCOPE | Alcon Laboratories | EPT | Class I | 1976-12-16 |
| K760469 | CLEANSING AGENT, NEW WOUND (DEBRISSU) | Pharmaseal Laboratories | KOZ | Class I | 1976-12-16 |
| K760760 | CATHETER, INTRAVASCULAR (ARGYLE IV SK) | Sherwood Medical Industries | JCY | Class I | 1976-12-09 |
| K760912 | DRESSING CHANGE KIT | American Hospital Supply Corp. | KGO | Class I | 1976-12-02 |
| K761094 | UVA PHOTOTHERAPY SYSTEM | Dermatron Corp. | KGL | Class II | 1976-12-02 |
| K761072 | P.S.M. JUSTA COVER | The Owenby Co. | FXP | Class I | 1976-12-02 |
| K761096 | VANDERBILT PITUITARY RETRACTOR | Codman & Shurtleff, Inc. | GAD | Class I | 1976-11-30 |
| K760815 | FITTING/DIALYZER | Cobe Laboratories, Inc. | FTG | Class II | 1976-11-19 |
| K760977 | CHARNLEY FEMUR DRILL #1 AND #2 | Codman & Shurtleff, Inc. | HWE | Class I | 1976-11-16 |
| K760953 | DEEP FREEZE SYSTEM (DFS-30) | Spembly Medical , Ltd. | GEH | Class II | 1976-11-16 |
| K760991 | SURGINE FACE MASK | Surgikos, Inc. | FXX | Class II | 1976-11-16 |
| K760560 | CATH CARE KIT | Walpak Co. | KGO | Class I | 1976-11-12 |
| K760497 | TRAY, SERVICE | Landmark Plastics | LRP | Class I | 1976-11-12 |
| K760554 | APPAREL, BARRIER SCRUB | Surgikos, Inc. | FYA | Class II | 1976-11-12 |
| K760507 | FORCEP, THUMB | Acme United Corp. | GEN | Class I | 1976-11-12 |
| K760890 | BARRIER IMPERVIOUS S-OCKINETTE | Surgikos, Inc. | KKX | Class II | 1976-11-11 |
| K760932 | BOUNDARY FABRIC III SURGICAL DRAPE | Procter & Gamble Mfg. Co. | KKX | Class II | 1976-11-11 |
| K760903 | BARRIER FABRIC 450 SURGICAL GOWNS | Surgikos, Inc. | FYA | Class II | 1976-11-11 |
| K760933 | BARRIER UNIVERSAL SHEET | Surgikos, Inc. | KKX | Class II | 1976-11-11 |
| K760864 | BARRIER FABRIC 450 SPECIALTY GOWN | Surgikos, Inc. | FYA | Class II | 1976-11-03 |
| K760778 | T-TUBE DRAIN, ROUND | Heyer Schulte Corp. | GCY | Class I | 1976-11-03 |
| K760807 | BARRIER GENERAL SURGERY PACK | Surgikos, Inc. | KKX | Class II | 1976-11-03 |
| K760811 | GLOVE, SURGEON | Sherwood Medical Industries | KGO | Class I | 1976-11-03 |
| K760742 | CS-76 AND/OR CRYOCARE I | Frigitronics of Connecticut, Inc. | GEH | Class II | 1976-11-03 |
| K760865 | BARRIER FASHION BONNET | Surgikos, Inc. | FXY | Class II | 1976-11-03 |
| K760867 | STERILE STOCKINETTE | Abco Dealers, Inc. | KKX | Class II | 1976-11-03 |
| K760855 | BARRIER SURGICAL HOOD | Surgikos, Inc. | FXY | Class II | 1976-11-03 |
| K760861 | SURGICAL CORP. | Surgikos, Inc. | FYF | Class I | 1976-11-03 |
| K760850 | PARKES HUMP GAUGE STRAIGHT 7 (18 CM) | V. Mueller O.V. Baxter Healthcare Corp. | GDH | Class I | 1976-11-03 |
| K760734 | REGULAR AND WIDE SKIN STAPLES | ETHICON, Inc. | GDT | Class I | 1976-11-03 |
| K760384 | STOPPERS | B. Braun Instruments | KGZ | Class I | 1976-11-02 |
| K760382 | CONNECTORS | B. Braun Instruments | GCD | Class I | 1976-11-02 |
| K760524 | CATHETER CONNECTOR, ARGYLE TUBING | Sherwood Medical Industries | GCD | Class I | 1976-11-02 |
| K760385 | EXTENSION SETS | B. Braun Instruments | KGZ | Class I | 1976-11-02 |
| K760389 | CANNULA, IV | B. Braun Instruments | FGY | Class I | 1976-11-02 |
| K760779 | BARNER SHOE COVERS & COVERBOOTS | Surgikos, Inc. | FXP | Class I | 1976-11-02 |
| K760700 | SILASTIC BRAND G7-2090A | Dow Corning Corp. Healthcare Industries Materials | GCY | Class I | 1976-11-02 |
| K760390 | CATHETER, VEIN (BRAUNULA T) | B. Braun Instruments | JCY | Class I | 1976-11-02 |
| K760391 | CATHETER, VEIN (BRAUNULA) | B. Braun Instruments | JCY | Class I | 1976-11-02 |
| K760562 | CHIN IMPLANTS | Mediplast Laboratories, Inc. | FWP | Class II | 1976-11-02 |
| K760456 | TABLE, HAND SURGI | Stryker Corp. | FWZ | Class I | 1976-11-02 |
| K760383 | STOPCOCKS | B. Braun Instruments | KGZ | Class I | 1976-11-02 |
| K760428 | SUTURE RACK & NEEDLE COUNTER | Kleen Test Products | FSM | Class I | 1976-11-02 |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | B. Braun Instruments | JCY | Class I | 1976-11-02 |
| K760380 | INTRAVENOUS TRANSFER SET (INTRAFIX) | B. Braun Instruments | JCY | Class I | 1976-11-02 |
| K760579 | INSTRUMENT RACK FOR DAWSON-YUHL INSTR. | V. Mueller O.V. Baxter Healthcare Corp. | FSM | Class I | 1976-11-02 |
| K760686 | CRYOLYZER ALPHA (CRYOSURG.EQUIP.) | Cryo-Labs, Inc. | GEH | Class II | 1976-11-01 |
| K760745 | YASARGIL SUCTION TUBE - SMALL | Codman & Shurtleff, Inc. | GCY | Class I | 1976-11-01 |
| K760775 | TERUMO DISPOSABLE SPINAL NEEDLE | Terumo America, Inc. | GAA | Class I | 1976-11-01 |
| K760747 | YASARGIL SUCTION TUBE - MEDIUM | Codman & Shurtleff, Inc. | GCY | Class I | 1976-11-01 |
| K760601 | ARGYLE SUCTION CONTROL KIT | Sherwood Medical Co. | GCY | Class I | 1976-11-01 |
| K760746 | YASARGIL SUCTION TUBE - LARGE | Codman & Shurtleff, Inc. | GCY | Class I | 1976-11-01 |
| K760722 | BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLE | Birtcher Corp. | GEI | Class II | 1976-11-01 |
| K760353 | CRYOLYZER ALPHA | Pilling Co. | GEH | Class II | 1976-10-29 |
| K760357 | SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI) | V. Mueller O.V. Baxter Healthcare Corp. | FZG | Class II | 1976-10-27 |
| K760703 | SPONGE AND GAUZE FORCEP PART #S-417-9 | Acme United Corp. | GEN | Class I | 1976-10-21 |
| K760605 | LIGHTCAST II CARBIDE BLADE | Merck, Sharp & Dohme | GES | Class I | 1976-10-05 |
| K760650 | RETRACTOR, GERBODE STERNAL | Dilling Co. | GAP | Class II | 1976-09-21 |
| K760423 | ELECTROLYSIS MACHINE (PERMATRON) | Epco Hair Removal Corp. | KCX | Class I | 1976-09-15 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.