Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 52
- Latest Decision
- 1983-01-26
Clearances · page 151 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K830018 | SAFE-T ARM BOARD | Harvey A. Turner, M.D. | BTX | Class I | 1983-01-26 |
| K823086 | DESERET SURGEON'S GLOVE ACCESSORY | Parke-Davis Co. | KGO | Class I | 1983-01-17 |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Medcare Products | FSM | Class I | 1983-01-14 |
| K823760 | PRICK-TEST NEEDLE | Cordis Corp. | FMK | Class II | 1983-01-14 |
| K823855 | MEDCARE INCISION & DRAINAGE TRAY | Medcare Products | FSM | Class I | 1983-01-14 |
| K823284 | STRYKER CONSTAVAC | Stryker Corp. | GCY | Class I | 1983-01-14 |
| K823856 | MEDCARE GENERAL PURPOSE TRAY | Medcare Products | FSM | Class I | 1983-01-14 |
| K823438 | HANDI-TRAY | Treace Medical, Inc. | FSM | Class I | 1983-01-14 |
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | American Sterilizer Co. | BWN | Class I | 1983-01-14 |
| K823674 | HIGH FREQUENCY EPILATOR CB-2 | R. A. Fischer Co. Corp. | KCW | Class I | 1983-01-14 |
| K823054 | DRAPE, SURGICAL ANGIOGRAPHY | Triad Medical Division | KKX | Class II | 1983-01-12 |
| K823689 | 3M SCOTCHPLATE 51148 SMALL CONDUCTIVE | 3M Company | GEI | Class II | 1983-01-12 |
| K823670 | E.S. PENCIL | Surgicare Scientific Laboratory, Inc. | GEI | Class II | 1983-01-12 |
| K822925 | BOUNDARY SINGLE-USE GOWNS | The Buckeye Cellulose Corp. | FYA | Class II | 1983-01-12 |
| K823671 | NO-GAUZE LAPAROTOMY SPONGE | Surgilite Intl., Inc. | GDY | Class I | 1983-01-09 |
| K823888 | 3M FRASCIA STAPLING SYSTEM | 3M Company | GEF | Class I | 1983-01-09 |
| K823924 | MODEL SSE4 ELECTROSURGICAL GENERATOR | Valleylab, Inc. | GEI | Class II | 1983-01-09 |
| K822857 | CPI PRINTER | Cardiac Pacemakers, Inc. | KAG | Class I | 1983-01-08 |
| K823491 | BIRT-A-SWITCH DSP #712 | Birtcher Corp. | GEI | Class II | 1983-01-07 |
| K823430 | INSTRA-SAFE | Instranetics, Inc. | FSM | Class I | 1983-01-07 |
| K822641 | GORE-TEX BARRIER SURG. DRAPES & GOWNS | W. L. Gore & Associates, Inc. | KKX | Class II | 1983-01-07 |
| K823078 | SPUNGUARD FACE MASK | Kimberly-Clark Corp. | FXX | Class II | 1983-01-07 |
| K823694 | VASCU-STATT APPROXIMATOR | Scanlan Intl., Inc. | HRQ | Class I | 1983-01-07 |
| K823516 | ESA CAMERA | Concept, Inc. | FWH | Class I | 1982-12-30 |
| K823496 | ARTHROSCOPIC IRRIGATION SETS-2C4030/31 | Travenol Laboratories, S.A. | GBX | Class I | 1982-12-28 |
| K822902 | MINI-VAC DRAIN SYSTEM | Angus Medical Co. | GCY | Class I | 1982-12-28 |
| K823412 | ARM BOARD W/I.V COVERING | Sage Products, Inc. | BTX | Class I | 1982-12-15 |
| K823534 | STEREOMED CAMERA | Diseases of the Skin Clinic, P.A. | FTT | Class I | 1982-12-15 |
| K821505 | AIRWAY TEMPERATURE SENSOR | Mon-A-Therm, Inc. | GEI | Class II | 1982-12-09 |
| K823083 | ELECTROSURGICAL UNIT | Kelleher Corp. | GEI | Class II | 1982-12-07 |
| K823184 | BIPOLAR COAGULATOR #9620/9621 | Concept, Inc. | GEI | Class II | 1982-12-03 |
| K823360 | SURGICAL LIGHT | Amsco Co. | FTD | Class II | 1982-12-03 |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | The Buckeye Cellulose Corp. | GEC | Class I | 1982-11-22 |
| K823011 | VC III | Teknar, Inc. | EPT | Class I | 1982-11-08 |
| K822963 | SURGICAL PRODUCTS, SKIN STAPLE REMOVER | Temp-Stik Corp. | FZQ | Class I | 1982-11-08 |
| K822987 | DRESSING SPONGE | Hermitage Hospital Products, Inc. | NAB | Class I | 1982-11-05 |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | American Hospital Supply Corp. | NAB | Class I | 1982-11-05 |
| K823061 | BRUSH, SCRUB, OPERATING ROOM | Seamless Hospital Products Co. | GEC | Class I | 1982-11-05 |
| K822145 | COMPLETE | Richard-Allan Medical Ind., Inc. | FZQ | Class I | 1982-10-22 |
| K822893 | G.E.V. DISPOSABLE SCALPELS | Ascep, Inc. | GDX | Class I | 1982-10-22 |
| K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE | Xomed, Inc. | KIJ | Class I | 1982-10-22 |
| K822865 | SURGI-SCRUB V | Acme United Corp. | GEC | Class I | 1982-10-18 |
| K822080 | ADHESIVE WOUND COVER FILM | Hollister, Inc. | NAD | Class I | 1982-10-15 |
| K822130 | FRANCIS NASAL TUBE | Tekna Med Corp. | FZE | Class II | 1982-10-13 |
| K822158 | OPEN HEART TRAY (CUSTOM DESIGNED) | Megaplast, Inc. | KDD | Class I | 1982-10-13 |
| K822623 | LAPAROTOMY SPONGE | Hermitage Hospital Products, Inc. | GDY | Class I | 1982-10-13 |
| K822510 | SUCTION CATHETER W/STERILE WATER | Medine Dynacor | GBX | Class I | 1982-10-13 |
| K822264 | NAGASHIMA SN OPERATOR'S CHAIR | Kelleher Corp. | GBB | Class I | 1982-10-13 |
| K822591 | TISSUE FORCEPS | Medcare Products | GEN | Class I | 1982-10-13 |
| K822847 | INSTA-HOLD | Taub Industries | KKX | Class II | 1982-10-08 |
| K822201 | EAR CANNULAS | Kelleher Corp. | FGY | Class I | 1982-10-06 |
| K822562 | ODONTO-SCOPE | Treace Medical, Inc. | FSO | Class I | 1982-10-06 |
| K822749 | PILLING DIAMOND KNIFE | Narco Scientific | GDX | Class I | 1982-10-06 |
| K822569 | TYMPANOPLASTY & SKIN DISSECTORS | Kelleher Corp. | GDI | Class I | 1982-10-06 |
| K822355 | DISP. METAL & PLASTIC ELECTROSURG. DEV | Valleylab, Inc. | GEI | Class II | 1982-09-22 |
| K822572 | POLYHESIVE PATIENT RETURN ELECTRODE | Valleylab, Inc. | GEI | Class II | 1982-09-21 |
| K822345 | DISPOSABLE LINEAR STAPLER (LSF) | ETHICON, Inc. | GDW | Class II | 1982-09-21 |
| K822513 | MODEL #2000 HI-TEMP & #3000 LOW-TEMP | Surgicare Scientific Laboratory, Inc. | GEI | Class II | 1982-09-21 |
| K822405 | CONDUCTIVE ADHESIVE DISPERSIVE ELECTRO | Edward Weck, Inc. | GEI | Class II | 1982-09-21 |
| K822092 | CAMERON-MILLER #40-1516 | Cameron-Miller, Inc. | GEI | Class II | 1982-09-21 |
| K822491 | DISPOSABLE GRASPING FORCEPS | Van-Tec, Inc. | GEN | Class I | 1982-09-17 |
| K822204 | ENT MALLETS | Kelleher Corp. | GFJ | Class I | 1982-09-17 |
| K822553 | PRESSURE-QUET TOURNIQUET | Nutec Med, Inc. | GAX | Class I | 1982-09-17 |
| K822483 | MULTIPLE SCRUB SUIT | Surgilite Intl., Inc. | FXO | Class I | 1982-09-17 |
| K822481 | MULTIPLE SURGICAL MASK | Surgilite Intl., Inc. | FXX | Class II | 1982-09-17 |
| K822448 | SCISSORS, VARIOUS | J. Sklar Mfg. Co., Inc. | FZT | Class I | 1982-09-14 |
| K821769 | MICROKNIFE | Biological & Environmental Control Laboratories | EMF | Class I | 1982-09-14 |
| K822490 | DEFLECTING CYTOLOGY BRUSH | Van-Tec, Inc. | GEE | Class I | 1982-09-14 |
| K822563 | OPHTHALMIC MICROSCOPE | Treace Medical, Inc. | HRM | Class I | 1982-09-14 |
| K822561 | MICROSCOPE | Treace Medical, Inc. | EPT | Class I | 1982-09-14 |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Surgi-Quip Inc.U | FSE | Class I | 1982-09-14 |
| K822373 | EAR SURGERY SPECULUM | Treace Medical, Inc. | EPY | Class I | 1982-09-09 |
| K822370 | UNIVERSAL SPECULUM HOLDER | Treace Medical, Inc. | EPY | Class I | 1982-09-09 |
| K822318 | ARGYLE MEDIASTINAL DRAIN | Sherwood Medical Co. | GBS | Class I | 1982-08-27 |
| K822278 | ENT FORCEPS | Kelleher Corp. | GEN | Class I | 1982-08-27 |
| K822365 | CENTURION SKIN STAPLE REMOVER | Tri-State | GDT | Class I | 1982-08-27 |
| K822251 | EXAMINATION & TREATMENT CHAIRS | Kelleher Corp. | GBB | Class I | 1982-08-27 |
| K822209 | AUTOLANCET | Bd Becton Dickinson Vacutainer Systems Preanalytic | FMK | Class II | 1982-08-27 |
| K822181 | BINOCULAR OPER. MICROSCOPES & ACCESSOR | Kelleher Corp. | FSO | Class I | 1982-08-27 |
| K827890 | FOLDALITE UNIT | National Biological Corp. | FTC | Class II | 1982-08-23 |
| K822167 | STILL ENDOSCOPIC CAMERAS | Kelleher Corp. | FXM | Class I | 1982-08-20 |
| K822070 | ELITE #MPS 101 ELECTROSURGICAL SWITCH | Delta Medical Electronics, Inc. | GEI | Class II | 1982-08-19 |
| K822069 | ELIMINATOR #BPS 201 BIPOLAR ELECTRO | Delta Medical Electronics, Inc. | GEI | Class II | 1982-08-19 |
| K822062 | BALL TIP COAGULATING ELECTRODES | American Endoscopy, Inc. | GEI | Class II | 1982-08-19 |
| K822072 | MPI ELECTROSURGICAL CAPACTIVE DISPER | Medical Plastics, Inc. | GEI | Class II | 1982-08-19 |
| K822065 | KAM SUCKER | The Anspach Effort, Inc. | KDC | Class I | 1982-08-16 |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | American Heyer Schulte | GCY | Class I | 1982-08-16 |
| K822263 | VARIOUS TYPES OF TONSILS HEMOSTATS | Kelleher Corp. | HRQ | Class I | 1982-08-16 |
| K822011 | SHEA'S EAR SPECULUM HOLDER PORT MANNS | Kelleher Corp. | JYK | Class I | 1982-08-12 |
| K822108 | CEMENT-PICK | Bio-Blitz, Inc. | GAF | Class I | 1982-08-11 |
| K822164 | EAR SPECULI | Kelleher Corp. | EPY | Class I | 1982-08-11 |
| K822014 | NAGASHIMA SU-A CEILING MOUNT UNIT FOR | Kelleher Corp. | EPT | Class I | 1982-08-06 |
| K821169 | MPI MON-IT II, SMART SAFETY SYSTEM | Medical Plastics, Inc. | GEI | Class II | 1982-08-06 |
| K821321 | SNYDER DEBRIBEMENT SYSTEM LDP-1 | Snyder Laboratories, Inc. | BTA | Class II | 1982-08-06 |
| K821246 | MELOLIN | Smith & Nephew, Inc. | NAB | Class I | 1982-08-06 |
| K821994 | DISPOSABLE LINEAR STAPLER-(LSR) | ETHICON, Inc. | GDW | Class II | 1982-08-03 |
| K822009 | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | EPT | Class I | 1982-07-30 |
| K821921 | STAND, SURG. INSTRUMENT & DRESSING | Emerson-Sack-Warner Corp. | FSH | Class I | 1982-07-30 |
| K822015 | BINOCULAR OPERATING MICROSCOPES AND | Kelleher Corp. | FSO | Class I | 1982-07-30 |
| K822047 | INTERSORB DRY BURN VEST & PANTS | Chesebrough-Pond'S U.S.A. Co. | NAB | Class I | 1982-07-28 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.