Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 49
- Latest Decision
- 1982-04-29
Clearances · page 153 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K820650 | LPS 1118 | L.P. Systems Corp. | KCW | Class I | 1982-04-29 |
| K820902 | MULTIPERFECTEMP | Kay Medical, Inc. | GEI | Class II | 1982-04-26 |
| K820969 | BIOPSY FORCEPW W/SMALL OVAL CUPS | Mill-Rose Laboratory | GEN | Class I | 1982-04-26 |
| K820967 | BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS | Mill-Rose Laboratory | GEN | Class I | 1982-04-26 |
| K820972 | BIOPSY FORCEPS W/OVAL CUPS | Mill-Rose Laboratory | GEN | Class I | 1982-04-26 |
| K820970 | RETRIEVAL FORCEPS W/RATTOOTHED JAWS | Mill-Rose Laboratory | GEN | Class I | 1982-04-26 |
| K820968 | RETRIEVAL FORCEPS W/ALLIGATOR JAWS | Mill-Rose Laboratory | GEN | Class I | 1982-04-26 |
| K820980 | BIOPSY FORCEPS W/OVAL CUP & NEEDLE | Mill-Rose Laboratory | GEN | Class I | 1982-04-26 |
| K820983 | HOT BIOPSY FORCEPS W/ROUND CUPS | Mill-Rose Laboratory | GEI | Class II | 1982-04-26 |
| K820289 | ANTHROSCOPIC SURGICAL TABLE | The Anspach Effort, Inc. | FWZ | Class I | 1982-04-21 |
| K820160 | HOLLISTER WOUND EXUDATE ABSORBER | Hollister, Inc. | KOZ | Class I | 1982-04-21 |
| K813224 | CERAVITAL CERAMIC EAR CANAL WALL PROSTH | Xomed, Inc. | ESF | Class II | 1982-04-21 |
| K820823 | MULTIPLE, MODEL #17 | Midmark Corp. | LGX | Class I | 1982-04-21 |
| K820681 | CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT | Sybron Corp. | FSY | Class II | 1982-04-15 |
| K820893 | DISPOSABLE SURGICAL FACE MASK | Anago, Inc. | FXX | Class II | 1982-04-14 |
| K820867 | PERCUTANEOUS NEPHROSTOMY SET | Van-Tec, Inc. | GBO | Class I | 1982-04-13 |
| K820730 | MICRO CISE DIAMOND SCALPEL | CooperVision, Inc. | GDX | Class I | 1982-04-09 |
| K820494 | SYBRON BOVIE CSV HAND CONTR. ELECTROSURG | Sybron Corp. | GEI | Class II | 1982-04-09 |
| K820626 | OPTI-DISC | Video-Medical Devices, Ltd. | KQM | Class I | 1982-04-09 |
| K820638 | PEDIATRIC SUCKER | 3M Health Care, Sarns | KDC | Class I | 1982-04-09 |
| K820625 | HEMALET AUTOMATIC LANCET DEVICE | Medprobe Laboratories | FMK | Class II | 1982-04-09 |
| K820492 | SPECTRA305 | Ultralite | FTC | Class II | 1982-03-31 |
| K820713 | BALLARD MEDICAL PRODUCTS ELECTRO-SURG | Ballard Medical Products | GEI | Class II | 1982-03-26 |
| K820636 | STORZ #6500 POWER EXAMINATION CHAIR | Storz Instrument Co. | GBB | Class I | 1982-03-26 |
| K820193 | GORE-TEX TISSUE REINFORCEMENT PATCH | W. L. Gore & Associates, Inc. | FTL | Class II | 1982-03-26 |
| K813581 | CRUCIATE LIGAMENT BUTTON | Biomet, Inc. | KGS | Class I | 1982-03-23 |
| K820601 | REPLACEMENT SAW BLADES FOR STRYKER AIR | Micro-Aire Surgical Instruments, Inc. | GFA | Class I | 1982-03-23 |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | CIVCO Medical Instruments Co., Inc. | DWO | Class I | 1982-03-23 |
| K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | David Simmonds Co., Inc. | BWN | Class I | 1982-03-23 |
| K820464 | HOLLISTER ODOR ABSORBING WOUND PAD | Hollister, Inc. | NAB | Class I | 1982-03-23 |
| K820664 | DISPOSABLE ELECTRODE | Trident Surgical Corp. | HAM | Class II | 1982-03-19 |
| K813360 | DERMAFILE (CAT. # 38 | Exco, Inc. | KKX | Class II | 1982-03-18 |
| K820161 | AXIOM LIG-A-BOOTS | Axiom Medical, Inc. | KDC | Class I | 1982-03-15 |
| K812225 | METEC HELARIUM LOUNGE & SKY UNITS | Klafs Sunlight Corp. | FTC | Class II | 1982-03-15 |
| K820502 | SILOAM SAVE-A-NEEDLE | Siloam, Inc. | GAA | Class I | 1982-03-15 |
| K820413 | AEGIS NON-ADHERENT DRESSING | Professional Medical Products, Inc. | NAB | Class I | 1982-03-12 |
| K820446 | CATHETER, MULTIPLE LUMEN | Dlp, Inc. | GBP | Class I | 1982-03-11 |
| K813097 | ANAGO STERILE PRODUCTS; STOCKINETTES | Anago, Inc. | KKX | Class II | 1982-03-10 |
| K820333 | MONOJECTOR MONOLET LANCER | Sherwood Medical Co. | FMK | Class II | 1982-03-10 |
| K820377 | PILLING IDENTI-LOOPS | Narco Scientific | GAD | Class I | 1982-03-10 |
| K820423 | SUTURE REMOVAL TRAY | Megaplast, Inc. | KDD | Class I | 1982-03-10 |
| K820474 | P-S SUCTION RESERVIOR | Pudenz-Schulte Medical Research Corp. | GCY | Class I | 1982-03-08 |
| K820344 | ROWE SHOULDER INSTR. FOR BANKHART REPAIR | New England Surgical Instrument Corp. | HTD | Class I | 1982-03-08 |
| K820327 | MODEL 450XL CO2 SURGICAL LASER | Lumenis, Inc. | GEX | Class II | 1982-03-08 |
| K820363 | DISPOSABLE SURGICAL GARMENTS | Alphamedix, Inc. | FYA | Class II | 1982-03-08 |
| K820198 | DERMA-AID | Winfield Laboratories, Inc. | NAB | Class I | 1982-03-05 |
| K820280 | SPECTRA 305/350 | Ultralite | KGL | Class II | 1982-03-05 |
| K820291 | KNEE SUPPORT FOR X-RAY & SURGERY | The Anspach Effort, Inc. | FWZ | Class I | 1982-03-05 |
| K820290 | SELF RETAINING RETRACTOR FOR HAND SURG | The Anspach Effort, Inc. | GAD | Class I | 1982-03-05 |
| K820259 | STERILE CYTOLOGY BRUSHES | American Endoscopy, Inc. | GEE | Class I | 1982-03-05 |
| K820338 | IMPACT, MODELS 306/307 | Impact Instrumentation, Inc. | BTA | Class II | 1982-03-02 |
| K820123 | SUNFLOWER | Solana, Inc. | FTC | Class II | 1982-03-01 |
| K820101 | SHARPLAN 720 CO2 SURGICAL LASER | Laser Industries , Ltd. | GEX | Class II | 1982-02-24 |
| K820116 | BOUNDARY | The Buckeye Cellulose Corp. | FYA | Class II | 1982-02-23 |
| K820281 | MICRO-AIRE REPLACEMENT DRILL BURS | Micro-Aire Surgical Instruments, Inc. | GFF | Class I | 1982-02-23 |
| K820332 | NEEDLE & BLADE COUNTER | Abco Dist. | FSM | Class I | 1982-02-23 |
| K820330 | IMPACT, MODEL E-12 | Impact Instrumentation, Inc. | JCX | Class II | 1982-02-23 |
| K820331 | IMPACT, MODEL 302 | Impact Instrumentation, Inc. | JCX | Class II | 1982-02-23 |
| K820339 | ISLAM BONE MARROW BIOPSY NEEDLE | Downs Surgical , Ltd. | GDM | Class I | 1982-02-23 |
| K820156 | THEIR ELECTRO SURGICAL COUTERY PENCIL | Shannon Group | GEI | Class II | 1982-02-18 |
| K813463 | SIL-V-UR CHEST CATHETER | C.R. Bard, Inc. | GBS | Class I | 1982-02-12 |
| K820108 | TOPPER SPONGES | Stan-Pak Ent. | NAB | Class I | 1982-02-12 |
| K812421 | STERILE DISPOSABLE SURGICAL GLOVES | Intermarket Latex, Inc. | KGO | Class I | 1982-02-10 |
| K820170 | MED-CARE EMERGENCY SHEARS | Medcare Products | FZT | Class I | 1982-02-05 |
| K820105 | COMBINE PAD OR ABD | Stan-Pak Ent. | NAB | Class I | 1982-02-05 |
| K820056 | TELFA STRIPS | Stan-Pak Ent. | NAB | Class I | 1982-02-05 |
| K820139 | SOF-ROL CAST PADDING | Stan-Pak Ent. | NAB | Class I | 1982-02-05 |
| K820158 | OLSEN #770 DISPOSABLE HOLSTER | Olsen Electro-Surgical Instruments, Inc. | KDC | Class I | 1982-02-05 |
| K820078 | DRAPE, SURGICAL | James L. Geraci & Associates, Inc. | KKX | Class II | 1982-02-04 |
| K820070 | MSI STERNUM ASPIRATION NEEDLE | Creative Research and Mfg., Inc. | GAA | Class I | 1982-02-04 |
| K820095 | TONSIL SPONGES | Stan-Pak Ent. | NAB | Class I | 1982-02-04 |
| K813637 | STOLTRONICS-LRS | Stoltronic Systems, Inc. | KCW | Class I | 1982-02-04 |
| K820096 | VAG PACKING | Stan-Pak Ent. | NAB | Class I | 1982-02-04 |
| K820053 | KERLIX FLUFFS | Stan-Pak Ent. | NAB | Class I | 1982-02-04 |
| K820097 | SHEET WADDING CAST PADDING | Stan-Pak Ent. | NAB | Class I | 1982-02-04 |
| K820098 | ROLLER GAUZE | Stan-Pak Ent. | NAB | Class I | 1982-02-04 |
| K820086 | CURITY SURGICAL SCRUB BRUSH SPONGE | The Kendal Co. | GEC | Class I | 1982-01-28 |
| K813338 | BIOPSY NEEDLES & TRAYS | American Pharmaseal Div. Ahsc | FSH | Class I | 1982-01-28 |
| K813337 | SKINNY CHIBA NEEDLE & TRAY | American Pharmaseal Div. Ahsc | FSH | Class I | 1982-01-28 |
| K813565 | RADIATION STERILIZED SURGEON'S GLOVES | Travenol Laboratories, S.A. | KGO | Class I | 1982-01-22 |
| K813419 | COMFORT CUSHION DRY BURN PAD III | American Convertors Div., American Pharmaseal | NAB | Class I | 1982-01-22 |
| K813450 | BOUNDARY SINGLE-USE DRAPES | The Buckeye Cellulose Corp. | KKX | Class II | 1982-01-22 |
| K813286 | PRE-PACK TENS | Cunningham Woodland, Inc. | GDY | Class I | 1982-01-22 |
| K813606 | SILICONE ELASTOMER INFUSION CATHETER | Quest Medical, Inc. | JCY | Class I | 1982-01-18 |
| K812760 | HI-TEMP CARDIOVASCULAR CAUTERY | Key Medical, Inc. | GEI | Class II | 1982-01-18 |
| K813416 | EXTERNAL BREAST PROSTHESIS | Surgical Appliance Industries, Inc. | GBI | Class I | 1982-01-18 |
| K813551 | SHEETS | Lancaster County Assoc. For the Blind | KKX | Class II | 1982-01-18 |
| K813595 | PARKE-DAVIS AEGIS ABOSRBENT SPONGES | Deseret Medical, Inc. | GDY | Class I | 1982-01-18 |
| K813030 | O.R. ARMBOARD COVER | Tecnol New Jersey Wound Care, Inc. | FWZ | Class I | 1982-01-18 |
| K813589 | SHARTPOINT EYED NEEDLES | S. Jackson, Inc. | GDL | Class I | 1982-01-18 |
| K812134 | INCISION & DRAINAGE TRAY | E.M. Adams | FSM | Class I | 1982-01-15 |
| K813587 | DISPOSABLE THORACIC CATHETER | Texas Medical Products, Inc. | GBS | Class I | 1982-01-12 |
| K813474 | MAXILL-AIR SINUS VENTILATION TUBE | Xomed, Inc. | KAM | Class I | 1982-01-12 |
| K812133 | WOUND CLOSURE INSTRUMENT TRAY | E.M. Adams | FSM | Class I | 1982-01-08 |
| K813335 | PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY | American Pharmaseal Div. Ahsc | FSH | Class I | 1982-01-08 |
| K813448 | POTTS-COURNAND STYLE NEEDLE | Ocean Medical Products, Ltd. | GAA | Class I | 1982-01-07 |
| K813460 | CHIBA SKINNY NEEDLE | Ocean Medical Products, Ltd. | GAA | Class I | 1982-01-07 |
| K813367 | CUATICO MYELOGRAPHY NEEDLES | Dlp, Inc. | GAA | Class I | 1982-01-05 |
| K813368 | DISPOSABLE CHIBA-TYPE NEEDLE | Dlp, Inc. | GAA | Class I | 1982-01-05 |
| K813390 | BONDARY SINGLE-USE OR GOWN | The Buckeye Cellulose Corp. | FYA | Class II | 1982-01-05 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.