Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 53
- Latest Decision
- 1981-08-03
Clearances · page 155 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K810796 | SUNTAN BOOTH | Gibson'S Mfg. Corp. | FTC | Class II | 1981-08-03 |
| K811855 | SKIN SCRUB KITS | Oem Medical Div. | KDD | Class I | 1981-07-31 |
| K811814 | TRIANGULAR BANDAGE | Abco Dealers, Inc. | NAB | Class I | 1981-07-31 |
| K811820 | BIPOLAR COAGULATING FORCEPS | New England Surgical Instrument Corp. | GEI | Class II | 1981-07-28 |
| K811958 | BOUNDARY REINFORCED OR GOWN | The Buckeye Cellulose Corp. | FYA | Class II | 1981-07-27 |
| K811686 | SURGICAL INSTRUMENTS | C.V.I., Inc. | GEN | Class I | 1981-07-20 |
| K811712 | TIP WIPE | Devon Industries, Inc. | KDC | Class I | 1981-07-20 |
| K811824 | CAUTERY CADDY PAD | Instranetics, Inc. | KDC | Class I | 1981-07-20 |
| K811759 | RETRACTING PROBES | American V. Mueller | GAD | Class I | 1981-07-20 |
| K811823 | SHARPS CADDY FB | Instranetics, Inc. | KDC | Class I | 1981-07-20 |
| K811822 | TIP-VU | Instranetics, Inc. | KDC | Class I | 1981-07-20 |
| K811717 | GATOR DRAPES | The Anspach Effort, Inc. | KQM | Class I | 1981-07-20 |
| K811834 | MICRO OSCILLATING SAW | Micro-Aire Surgical Instruments, Inc. | HSZ | Class I | 1981-07-20 |
| K811728 | CASTLE & RITTER MINOR SURG. & EXAM LT | Sybron Corp. | FTD | Class II | 1981-07-20 |
| K811707 | AXICUT DISPOSABLE SCALPEL | Neonatal Corp. | GDX | Class I | 1981-07-20 |
| K811557 | DEPUY HEMODRAIN | Depuy, Inc. | GCY | Class I | 1981-07-20 |
| K811771 | A.D.T. REUSABLE BONE MARROW NEEDLE | Lab Industries, Inc. | GAA | Class I | 1981-07-10 |
| K811501 | EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 | Rcx-Western, Inc. | KCW | Class I | 1981-07-10 |
| K811503 | EPILATOR, BLEND-MODEL EB-200 & ET-1 | Rcx-Western, Inc. | KCW | Class I | 1981-07-10 |
| K811623 | SMR PARAGON CHAIR TABLE | Smr | LGX | Class I | 1981-07-02 |
| K811390 | CCS100 CRYOSURGICAL SYSTEM | Frigitronics of Connecticut, Inc. | GEH | Class II | 1981-06-16 |
| K811303 | ALTRACLUDE | R&H Medical, Inc. | KDC | Class I | 1981-06-16 |
| K811005 | CORB TM COUNTERROTATING BIOPSY NEEDLE | Zimmer, Inc. | HSZ | Class I | 1981-06-15 |
| K811419 | SPRIO-LOOP | Datamed, Inc. | BTX | Class I | 1981-06-12 |
| K811278 | EXTENDED TUMOR CALIPER | Mick Radio-Nuclear Instruments, Inc. | FTY | Class I | 1981-06-02 |
| K811029 | SUNLAMP | Williams & Connolly | FTC | Class II | 1981-06-02 |
| K811378 | PERCUTANEOUS DRAINING CATHETER | Medi-Tech, Inc. | GBW | Class I | 1981-06-02 |
| K811311 | SKYTRON ELITE SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | GBC | Class II | 1981-06-02 |
| K811280 | FLEX-TEMPLATE | Mick Radio-Nuclear Instruments, Inc. | KDC | Class I | 1981-06-02 |
| K803264 | SUNLAMP | Am Labs, Inc. | FTC | Class II | 1981-06-02 |
| K811191 | DAVIS & GECK NEEDLE/SHARPS COUNTER | Davis & Geck, Inc. | KDC | Class I | 1981-05-27 |
| K811203 | SAF SINGLE-USE AEROSOL FILTER | Sorensen Research | GCY | Class I | 1981-05-21 |
| K810843 | EPILATRON | Electrola | KCW | Class I | 1981-05-08 |
| K811190 | THREE MODELS OF TABLES, STOOLS, & LIGHTS | Midmark Corp. | LGX | Class I | 1981-05-08 |
| K810655 | DISPOSABLE SCRUB BRUSH | Dexide, Inc. | GEC | Class I | 1981-05-05 |
| K811120 | SURGICAL STAPLE REMOVER | Acme United Corp. | KDC | Class I | 1981-05-05 |
| K810920 | NDM DIATEMP INFANT ELECTROSURG. DISP. P. | Ndm Corp. | HAM | Class II | 1981-05-01 |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | Cunningham Woodland, Inc. | FSM | Class I | 1981-05-01 |
| K811086 | SUTURE REMOVAL SET(DISPLSABLE) | Cunningham Woodland, Inc. | KDD | Class I | 1981-05-01 |
| K810636 | VARIODRAIN | Colmed, Ltd. | GCY | Class I | 1981-05-01 |
| K810668 | HO-B-LITE VI UNIT | National Biological Corp. | KGL | Class II | 1981-04-23 |
| K810883 | OMED SILICONE INSTRUMENT COVERS | Omega-Med Intl., Inc. | KDC | Class I | 1981-04-23 |
| K810888 | BOUNDARY TUBING HOLDERS | The Buckeye Cellulose Corp. | FZX | Class I | 1981-04-23 |
| K810476 | B.J.'S UVA SUN TAN BED W/SUN ROOF | B.J. Ent. | FTC | Class II | 1981-04-23 |
| K810688 | THE SUNFACTORY | Wesgold Marketing, Inc. | FTC | Class II | 1981-04-23 |
| K810900 | CASTLE PROCEDURE AND RITTER EXAM. TABLES | Sybron Corp. | LGX | Class I | 1981-04-21 |
| K810788 | SURGICAL TUBE HOLDER | The Urology Group | FZX | Class I | 1981-04-17 |
| K810909 | MICRO CAUTERY | Key Medical, Inc. | HAM | Class II | 1981-04-17 |
| K810785 | SKIN STAPLE REMOVER | Rowley Mfg. Co. | KDC | Class I | 1981-04-10 |
| K810720 | I.M. SCALPEL HANDLE | Instrument Makar, Inc. | GDZ | Class I | 1981-04-03 |
| K810628 | ELECTROSURGICAL CUTTING & COAGULATION | Intermedics, Inc. | JOS | Class II | 1981-04-03 |
| K810080 | VASCULAR TIE (VAS-TIE) | Sil-Med Corp. | KDC | Class I | 1981-04-02 |
| K810627 | MODEL 1301 BIOTAC (TM) | Progress Mankind Technology | GEA | Class I | 1981-04-02 |
| K810681 | MEDI-LANCE | Medicore, Inc. | FMK | Class II | 1981-03-26 |
| K810685 | SUTURE REMOVAL KIT | Medical Action Industries, Inc. | GEN | Class I | 1981-03-26 |
| K810531 | PERI-PATCH PERITONEAL CATHETER EXTENSION | Quinton, Inc. | KGZ | Class I | 1981-03-24 |
| K810530 | PERI-PATCH GLUE MOLD | Quinton, Inc. | KGZ | Class I | 1981-03-24 |
| K810409 | MODEL C2100-SERIES OPHTHALMIC CRYOPROBE | Valleylab, Inc. | GEH | Class II | 1981-03-20 |
| K810324 | AUTOMATIC HEMOCLIP APPLIER, 527700 | Edward Weck, Inc. | GDW | Class II | 1981-03-20 |
| K810572 | BLADE, HANDLE, SCALPEL FORCEPS, SURGERY | Technical Resources, Inc. | GES | Class I | 1981-03-20 |
| K810248 | MSI BONE MARROW BIOPSY NEEDLE W/J TIP | Creative Research and Mfg., Inc. | GAA | Class I | 1981-03-20 |
| K810358 | PHOTOTHERAPY LIGHT CHAMBER | Paul B. Elder Co. | KGL | Class II | 1981-03-20 |
| K810291 | STERILE/DISPOSABLE HSG TRAY | Unimar, Inc. | EYY | Class II | 1981-03-18 |
| K810512 | MEDISEAL CAMERA COVERS | Janin Group, Inc. | KQM | Class I | 1981-03-13 |
| K810433 | LOWER EXTREMITY SUPPORT SYSTEM-LESS | Walgen Medical Innoventions | FWZ | Class I | 1981-03-13 |
| K810428 | VICRYL | ETHICON, Inc. | FTL | Class II | 1981-03-13 |
| K810490 | GOMCO SUCTION PUMP CABINET CHANGE | Allied Healthcare Products, Inc. | BTA | Class II | 1981-03-13 |
| K810277 | PREGELLED DISPOS. ELECTROSURG. GROUND EL | Conmedcorp | GEI | Class II | 1981-03-11 |
| K810076 | PHERESIS NEEDLE ASSEMBLY | Haemonetics Corp. | GAA | Class I | 1981-03-05 |
| K810366 | FANCY TAN SUNBED | Fancy Tan, Inc. | LEJ | Class II | 1981-03-05 |
| K810416 | SARNS MINI-SUCKER | 3M Health Care, Sarns | GCY | Class I | 1981-03-05 |
| K810273 | DAVOL ELECTRO MEDICAL SYSTEMS | C.R. Bard, Inc. | GEI | Class II | 1981-03-04 |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Alba Health Care | FYB | Class II | 1981-03-04 |
| K810292 | CAM-WRAP | Medline Industries, Inc. | FTA | Class II | 1981-03-04 |
| K810299 | FIBER OPTIC ADAPTERS#60-0891 | Aspen Laboratories, Inc. | HBI | Class II | 1981-02-27 |
| K810300 | FIBER OPTIC ADAPTERS#60-0893 | Aspen Laboratories, Inc. | HBI | Class II | 1981-02-27 |
| K810303 | TELEVISION CAMERA HOLDER FOR SURGERY | The Anspach Effort, Inc. | FXR | Class I | 1981-02-26 |
| K810269 | OMED FABRIC INSTRUMENT COVERS | Omega-Med Intl., Inc. | KDC | Class I | 1981-02-26 |
| K803067 | SURG-FLEX 10 LIGHT | Medical Products Development, Inc. | FSQ | Class II | 1981-02-26 |
| K810282 | OPERATING TABLE ACCESSORY CLAMP | Minnesota Scientific, Inc. | GBJ | Class I | 1981-02-26 |
| K810260 | OMED SILICONE LOOPS | Omega-Med Intl., Inc. | KDC | Class I | 1981-02-26 |
| K810337 | PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 | Nice-Pak Products, Inc. | GEC | Class I | 1981-02-26 |
| K810318 | PARKE-DAVIS NON-WOVEN SPONGE | Hospital Products Co. | NAB | Class I | 1981-02-26 |
| K810316 | SURGIKOS FACE MASK | Surgikos, Inc. | FXX | Class II | 1981-02-23 |
| K810353 | HARRIS CEMENT RESTRICTOR | Cintor Orthopaedic Div. | LZN | Class II | 1981-02-23 |
| K810158 | DAVOL SILICONE SHEATH SUMP DRAIN | C.R. Bard, Inc. | GBS | Class I | 1981-02-13 |
| K810207 | MINOR SURGERY LIGHT | Cavitron Corp. | GBC | Class II | 1981-02-13 |
| K810199 | DISPOSABLE SURGERY CAPS & HOODS | Anago, Inc. | FYF | Class I | 1981-02-13 |
| K803178 | ANSPACH MENISECTOMY KNIFE | The Anspach Effort, Inc. | FZS | Class I | 1981-02-13 |
| K802790 | SOLVALINE | Secol Co. | KKX | Class II | 1981-02-13 |
| K802485 | SEARLE VASCULAR LOOPS | G.D. Searle and Co. | KDC | Class I | 1981-02-12 |
| K810071 | STERILE SILICONE TUBING | Medspec Corp. | GBS | Class I | 1981-02-12 |
| K810014 | REPLACABLE BATTERY HI-TEMP CAUTERY | Medical Products Development, Inc. | HAM | Class II | 1981-02-12 |
| K810015 | MULTIHI-TEMP CAUTERY | Medical Products Development, Inc. | HAM | Class II | 1981-02-12 |
| K810045 | I.M. RETROGRADE BLADES | Hogan & Hartson | GFA | Class I | 1981-02-12 |
| K803055 | ELECTROSURGICAL TIP CLEANER & HOLDER | Devon Industries, Inc. | GEI | Class II | 1981-02-12 |
| K803145 | CONPHAR EYE PROTECTOR | Conphar, Inc. | HMP | Class I | 1981-02-05 |
| K810184 | LAPAROTOMY SPONGE | Medical Action Industries, Inc. | GDY | Class I | 1981-02-04 |
| K803311 | LL100 CRYOSURGICAL SYSTEM | Wallach Surgical Devices, Inc. | GEH | Class II | 1981-02-04 |
| K810112 | SWR DISPOSABLE PREP RAZOR | G.D. Searle and Co. | KDC | Class I | 1981-02-04 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.