Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 51
- Latest Decision
- 1987-06-30
Clearances · page 137 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K872100 | BIOFILM TRANSORBENT ULCER AND WOUND DRESSING | The Bfgoodrich Co. | NAD | Class I | 1987-06-30 |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | New England Surgical Instrument Corp. | GEN | Class I | 1987-06-26 |
| K872209 | ARTHROPLASTY MALLET | New England Surgical Instrument Corp. | HXL | Class I | 1987-06-23 |
| K872003 | KINDERWRAP | The Kinder Co. | GAX | Class I | 1987-06-23 |
| K871894 | KCK INDUSTRIES' SURGICAL INSTRUMENTS | Kck Industries | GDX | Class I | 1987-06-23 |
| K872092 | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | Military Engineering, Inc. | KDG | Class I | 1987-06-23 |
| K871166 | ALLEVYN HYDROPHILIC POLYURETHANE DRESSING | Smith & Nephew, Inc. | NAD | Class I | 1987-06-16 |
| K871348 | SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE | Sharplan Lasers, Inc. | LNK | Class II | 1987-06-12 |
| K871077 | MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. | Radionics, Inc. | GEI | Class II | 1987-06-12 |
| K871926 | GRASPING FORCEP, 1.7MM | Arthropedics, Inc. | GEN | Class I | 1987-06-09 |
| K871906 | UNIMED SURGEON'S GOWNS | Unimed Hospital Supply Corp. | FYA | Class II | 1987-06-09 |
| K871927 | CUP BIOPSY FORCEP, 1.7MM | Arthropedics, Inc. | GEN | Class I | 1987-06-09 |
| K871982 | TOURNIQUET PRESSURE REGULATOR | Avec Scientific Design Corp. | KCY | Class I | 1987-06-09 |
| K871891 | KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER | KARL STORZ Endoscopy-America, Inc. | HSZ | Class I | 1987-06-05 |
| K871459 | SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG | Frass Survival Systems, Inc. | LRO | Class II | 1987-06-05 |
| K871717 | MODEL 28200C MICRO-ARTHROPLASTY SYSTEM | KARL STORZ Endoscopy-America, Inc. | HWE | Class I | 1987-06-05 |
| K871910 | SURGITEK DISPOSABLE BIPOLAR CORD | Dermacare Products, Inc. | GEI | Class II | 1987-06-01 |
| K871925 | STRAIGHT CUP CURRETTE, 1.7MM | Arthropedics, Inc. | FZS | Class I | 1987-06-01 |
| K871334 | LASE SYSTEM II | Lase, Inc. | GEX | Class II | 1987-06-01 |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | FSM | Class I | 1987-06-01 |
| K871901 | ULTRAFLOW | Custom Industries, Inc. | FZH | Class II | 1987-06-01 |
| K871923 | MICRO SCISSOR, 1.7MM | Arthropedics, Inc. | LRW | Class I | 1987-06-01 |
| K871068 | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER | Lifestream Int'L, Inc. | KKX | Class II | 1987-05-28 |
| K871322 | ADVANCED MEDICAL SYSTEMS, KIT | The Jarid Group, Inc. | LRO | Class II | 1987-05-27 |
| K871824 | MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K871822 | MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K870970 | MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT | Directed Energy, Inc. | GEX | Class II | 1987-05-26 |
| K870838 | MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE | Directed Energy, Inc. | GEX | Class II | 1987-05-26 |
| K871839 | MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K871820 | MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K871821 | MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K870837 | MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE | Directed Energy, Inc. | GEX | Class II | 1987-05-26 |
| K870971 | MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT | Directed Energy, Inc. | GEX | Class II | 1987-05-26 |
| K871823 | MCCONNELL ORTHOPEDIC TIBIAL POSITIONER | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K871840 | MCCONNELL ORTHOPEDIC ANKLE POSITIONER | Mcconnell Orthopedic | FWZ | Class I | 1987-05-26 |
| K871819 | MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER | Mcconnell Orthopedic | FWZ | Class I | 1987-05-22 |
| K871384 | APEX SUCTION CURETTE | Apex Medical, Inc. | GEA | Class I | 1987-05-22 |
| K871804 | MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY | Mcconnell Orthopedic | FWZ | Class I | 1987-05-19 |
| K871805 | MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT | Mcconnell Orthopedic | FWZ | Class I | 1987-05-19 |
| K871703 | MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM | Mcconnell Orthopedic | FWZ | Class I | 1987-05-19 |
| K871803 | MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP) | Mcconnell Orthopedic | FWZ | Class I | 1987-05-19 |
| K864869 | HR-5000 ELECTROSURGICAL DEVICE | Ime Co. , Ltd. | KCW | Class I | 1987-05-19 |
| K871706 | OPTHA PREP | Treace Medical, Inc. | HMT | Class II | 1987-05-18 |
| K871032 | MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | LNK | Class II | 1987-05-18 |
| K871029 | MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | LNK | Class II | 1987-05-18 |
| K871031 | 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH | Directed Energy, Inc. | LNK | Class II | 1987-05-15 |
| K871030 | MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | LNK | Class II | 1987-05-15 |
| K871535 | SMILJANIC BONE REPOSITIONING FORCEPS | Link America, Inc. | HTD | Class I | 1987-05-14 |
| K871435 | BARD EMS SYSTEM 6000 E.S.U. | C.R. Bard, Inc. | HAM | Class II | 1987-05-11 |
| K871070 | OMEGA SILICONE CHIN IMPLANT | Omega Silicone, Inc. | FWP | Class II | 1987-05-11 |
| K871073 | OMEGA BIVALVE NASAL SPLINTS | Omega Silicone, Inc. | FYI | Class I | 1987-05-11 |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | I M, Inc. | NAD | Class I | 1987-05-08 |
| K871595 | SURGICAL CAMERA ACCESSORIES | M.P. Video, Inc. | KQM | Class I | 1987-05-07 |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | FSM | Class I | 1987-05-07 |
| K870981 | MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR | Everest Medical Corp. | GEI | Class II | 1987-05-06 |
| K871314 | CRYOSURGICAL PROBE | Western Medical Research | GEH | Class II | 1987-04-28 |
| K871372 | CB-7 ELECTRONIC EPILATOR | R. A. Fischer Co. Corp. | KCW | Class I | 1987-04-28 |
| K871237 | SUN CAPSULE I & II SUNTANNING BOOTH | Sun Capsule, Inc. | FTC | Class II | 1987-04-23 |
| K871043 | (I) LV AND (II) HV SERIES CANNULA | Celebration Medical Products, Inc. | GEA | Class I | 1987-04-23 |
| K871287 | ORTHOPEDIC DRILL GUIDE | Orthopedic Systems, Inc. | HSZ | Class I | 1987-04-15 |
| K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY | North Coast Medi-Tek | GBZ | Class I | 1987-04-14 |
| K870161 | MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM | Coherent Medical Group | GEX | Class II | 1987-04-14 |
| K871071 | OMEGA DORSAL COLUMELLA IMPLANTS | Omega Silicone, Inc. | FZE | Class II | 1987-04-13 |
| K871244 | HOOD ESOPHAGEAL PROSTHESIS | Hood Laboratories | ESW | Class II | 1987-04-13 |
| K871074 | OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR | Omega Silicone, Inc. | FWP | Class II | 1987-04-10 |
| K871034 | LCA 2000 | Vistek Corp. | FTA | Class II | 1987-04-10 |
| K871190 | ANADIAS ZARA SYSTEM MALAR IMPLANTS | Anadias, Inc. | FWP | Class II | 1987-04-10 |
| K870517 | 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE | Coherent Medical Group | GEX | Class II | 1987-04-10 |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Medsurg Industries, Inc. | FSM | Class I | 1987-04-10 |
| K864887 | ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU | Bio Quantum Technologies, Inc. | GEX | Class II | 1987-04-10 |
| K864563 | MODEL LS 840, CO2 LASER | Cooper Lasersonics, Inc. | GEX | Class II | 1987-04-09 |
| K864562 | MODEL LS 860, CO2 LASER | Cooper Lasersonics, Inc. | GEX | Class II | 1987-04-09 |
| K871225 | HAND SURGERY TABLE EXTENSION | Orthopedic Systems, Inc. | FWZ | Class I | 1987-04-07 |
| K871195 | MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. | Military Engineering, Inc. | HXL | Class I | 1987-04-06 |
| K870149 | MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. | Radionics, Inc. | GEI | Class II | 1987-04-06 |
| K870942 | MVS FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | FST | Class II | 1987-04-03 |
| K871057 | MC-SERIES SURGICAL CAMERAS | M.P. Video, Inc. | FWB | Class I | 1987-04-03 |
| K870790 | REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 | Lifestream Int'L, Inc. | FTX | Class I | 1987-04-01 |
| K871056 | MEDICAM S-4 SURGICAL CAMERA | M.P. Video, Inc. | FWF | Class I | 1987-03-31 |
| K864948 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE | Bio Quantum Technologies, Inc. | LNK | Class II | 1987-03-30 |
| K870704 | CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET | American Pharmaseal Div. Ahsc | GBX | Class I | 1987-03-27 |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | American Pharmaseal Div. Ahsc | KOZ | Class I | 1987-03-27 |
| K870893 | MEDSURG CHIBA PTC NEEDLE | Medsurg Industries, Inc. | GAA | Class I | 1987-03-25 |
| K870882 | 45 DEGREE SHAVER | Bowen & Company, Inc. | HTZ | Class I | 1987-03-23 |
| K870881 | LOOSE BODY GRASPERS | Bowen & Company, Inc. | HTD | Class I | 1987-03-23 |
| K870559 | IODOSORB POWDER | Perstorp AB C/O Robert Joel Slomoff | KOZ | Class I | 1987-03-20 |
| K870373 | STERILE PROCEDURAL TRAYS | Dimed, Intl. | KDD | Class I | 1987-03-20 |
| K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | Adept-Med Intl., Inc. | GCZ | Class I | 1987-03-19 |
| K870896 | NOTCH-NEEDLE, WESCOTT STYLE | Ocean Medical Products, Ltd. | GAA | Class I | 1987-03-18 |
| K870898 | ULTRA-LUX LIGHT SOURCE | Medline Industries, Inc. | FSW | Class II | 1987-03-18 |
| K870397 | AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY | Sunkey Medical Manufacturing, Inc. | GEI | Class II | 1987-03-18 |
| K870784 | A.T.S. 1500 TOURNIQUET | Aspen Laboratories, Inc. | KCY | Class I | 1987-03-18 |
| K870781 | ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS | Buckman Co., Inc. | GEG | Class I | 1987-03-09 |
| K870778 | ACROMED WALLIE-HEINIG CURETTES | Buckman Co., Inc. | HTF | Class I | 1987-03-09 |
| K870617 | VARIOUS TYES OF SURGICAL GARMENTS | Greene International Corp. | FYF | Class I | 1987-03-09 |
| K870523 | HAWKINS BREAST LOCALIZATION NEEDLE | N-S Medical Products | GDM | Class I | 1987-03-09 |
| K870618 | VARIOUS TYPES OF SURGICAL GARMENTS | Kin Yuh Hung Co., Ltd. | FYF | Class I | 1987-03-09 |
| K870780 | ACROMED WALLIE-HEINIG OSTEOTOMES | Buckman Co., Inc. | HWM | Class I | 1987-03-09 |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | American Bentley | GEI | Class II | 1987-03-09 |
| K870094 | BUNN MODEL 530 ASPIRATOR | The John Bunn Co. | BTA | Class II | 1987-03-06 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.