Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 40
- Latest Decision
- 1989-05-05
Clearances · page 129 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K892285 | MODERN (STERILE SURGEON'S GLOVES) | Firestone Financial Corp. | KGO | Class I | 1989-05-05 |
| K891696 | DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | NAD | Class I | 1989-05-04 |
| K890818 | AUTO SUTURE DISPOSABLE SURGICAL TROCAR* | United States Surgical, A Division of Tyco Healthc | FZT | Class I | 1989-05-04 |
| K884791 | PERME-AID TRANSPARENT DRESSING, #11XX | Nitto Denko Technical Corp. | NAD | Class I | 1989-05-04 |
| K885066 | HEMATOME SYSTEM | Surgical Dynamics, Inc. | GET | Class I | 1989-05-01 |
| K892521 | CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE | Cymed, Inc. | FZS | Class I | 1989-05-01 |
| K891269 | MICROTRAK EIA AUTOWASHER | Syva Co. | JYC | Class I | 1989-05-01 |
| K892346 | SLT CONTACT LASER SYSTEMS (GYNECOLOGY) | Surgical Laser Technologies, Inc. | GEX | Class II | 1989-05-01 |
| K892233 | AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 1989-04-28 |
| K892345 | SLT CONTACT LASER SYSTEMS (NEUROSURGERY) | Surgical Laser Technologies, Inc. | GEX | Class II | 1989-04-27 |
| K891324 | HERMITEX SPONGE | Hermitage Hospital Products, Inc. | NAB | Class I | 1989-04-27 |
| K890354 | TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X | 3M Company | NAD | Class I | 1989-04-27 |
| K891308 | STERILE SURGICAL GLOVES | Carl Parker Associates, Inc. | KGO | Class I | 1989-04-26 |
| K884328 | CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE) | Select Sources, Inc. | KGO | Class I | 1989-04-26 |
| K892064 | LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN | Modern Rubber Industrial Co., Ltd. | KGO | Class I | 1989-04-26 |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | Ximed Medical Systems | GEX | Class II | 1989-04-21 |
| K891677 | COATED ISOLATION GOWN | Durante Intl., Inc. | FYC | Class II | 1989-04-20 |
| K884231 | SURGICAL 'LASER' DRAPE | Henley Intl. | KKX | Class II | 1989-04-20 |
| K891621 | STERILE SURGEONS' GLOVES | Albors-Menconi Latex Corp. | KGO | Class I | 1989-04-20 |
| K892118 | NON-STERILE MASKS AND CAPS | Paramount Products, Inc. | FYA | Class II | 1989-04-20 |
| K884633 | ARISTA AND ORIENT SURGICAL GLOVES | Durante Intl., Inc. | KGO | Class I | 1989-04-20 |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | James River Corp. | KGO | Class I | 1989-04-20 |
| K890841 | TITANIUM STAPLES | ETHICON, Inc. | GDW | Class II | 1989-04-19 |
| K891757 | KINETIC MODEL 1000 | Kinetic Biomedical Services, Inc. | FSY | Class II | 1989-04-19 |
| K891756 | KINETIC MODEL 500 | Kinetic Biomedical Services, Inc. | FSY | Class II | 1989-04-19 |
| K891758 | KINETIC MODEL 132 | Kinetic Biomedical Services, Inc. | FSS | Class II | 1989-04-19 |
| K891759 | KINETIC MODEL 330 | Kinetic Biomedical Services, Inc. | FSS | Class II | 1989-04-19 |
| K891141 | CARERITE FACE MASK | Cost Rite Health Products, Inc. | FXX | Class II | 1989-04-18 |
| K891537 | CORE BIOPSY NEEDLE, CATALOG CODE #54006 | Dlp, Inc. | GDM | Class I | 1989-04-18 |
| K891589 | 3MM DISPOSABLE SPECULA | Semantodontics, Inc. | FXG | Class I | 1989-04-18 |
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | Laivan Corp. | NAD | Class I | 1989-04-17 |
| K890729 | SUTURE REMOVAL KIT | Cypress Medical Products, Ltd. | LRO | Class II | 1989-04-17 |
| K885325 | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES | Frastec Wound Care Products, Inc. | NAD | Class I | 1989-04-17 |
| K891101 | NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING | Smith & Nephew United, Inc. | NAB | Class I | 1989-04-17 |
| K891211 | SURGICAL GOWN #2001 | Pro-Safe Professional Linens, Inc. | FYA | Class II | 1989-04-14 |
| K891212 | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | Pro-Safe Professional Linens, Inc. | FXO | Class I | 1989-04-14 |
| K891058 | DENTAL GOWN | Dispomed, Inc. | FYA | Class II | 1989-04-12 |
| K891901 | GOUGES, ALEXANDER, BISHOP, LUCAS | Zinnanti Surgical Instruments, Inc. | GDH | Class I | 1989-04-12 |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | GEN | Class I | 1989-04-12 |
| K891898 | SKIN HOOKS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | GDG | Class I | 1989-04-12 |
| K891894 | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | Zinnanti Surgical Instruments, Inc. | GEG | Class I | 1989-04-12 |
| K891899 | ELEVATORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | GEG | Class I | 1989-04-12 |
| K891052 | SPLASH GUARD GOGGLE | Dispomed, Inc. | FXX | Class II | 1989-04-12 |
| K891887 | OSTEOTOMES, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | GFI | Class I | 1989-04-12 |
| K891892 | ROLLET RETRACTOR | Zinnanti Surgical Instruments, Inc. | GAD | Class I | 1989-04-12 |
| K891886 | SCISSORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | LRW | Class I | 1989-04-12 |
| K891888 | CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER | Zinnanti Surgical Instruments, Inc. | FZS | Class I | 1989-04-12 |
| K891889 | OLIVECORONA SCISSORS | Zinnanti Surgical Instruments, Inc. | LRW | Class I | 1989-04-12 |
| K891053 | DENTAL BIB | Dispomed, Inc. | FYB | Class II | 1989-04-12 |
| K890287 | SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER | Sharplan Lasers, Inc. | GEX | Class II | 1989-04-12 |
| K891056 | SURGICAL CONE MASK | Dispomed, Inc. | FXX | Class II | 1989-04-12 |
| K891895 | SURGICAL LOUPES | Zinnanti Surgical Instruments, Inc. | FSP | Class I | 1989-04-12 |
| K891051 | SURGICAL FACE MASK-EAR LOOP | Dispomed, Inc. | FXX | Class II | 1989-04-12 |
| K891334 | ACU-CURETTE | Acuderm, Inc. | FZS | Class I | 1989-04-11 |
| K891001 | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE | Prescott'S, Inc. | HRM | Class I | 1989-04-11 |
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE | Manan Medical Products, Inc. | DWO | Class I | 1989-04-11 |
| K890941 | MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP | United States Surgical, A Division of Tyco Healthc | GDO | Class I | 1989-04-07 |
| K890672 | ABSORBENT GAUZE ROLL | Smith & Nephew United, Inc. | NAB | Class I | 1989-04-07 |
| K891409 | PRECEPT MICRO-GARD LASER MASK | Mars White Knight | FXX | Class II | 1989-04-07 |
| K891200 | RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS | Zinnanti Surgical Instruments, Inc. | LRW | Class I | 1989-04-06 |
| K891461 | SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG | Surgilase, Inc. | GEX | Class II | 1989-04-06 |
| K891203 | SCISSORS: THOREK, JORGENSEN, FINOCHIETTO | Zinnanti Surgical Instruments, Inc. | LRW | Class I | 1989-04-06 |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | Zinnanti Surgical Instruments, Inc. | GEN | Class I | 1989-04-06 |
| K891031 | KIRSCHNER RETRACTOR | Zinnanti Surgical Instruments, Inc. | GAD | Class I | 1989-04-06 |
| K891400 | MICRO CAUTERY NEEDLES | Zinnanti Surgical Instruments, Inc. | JOS | Class II | 1989-04-06 |
| K890321 | SLT CONTACT LASER SYSTEM (ORTHOPEDICS) | Surgical Laser Technologies, Inc. | GEX | Class II | 1989-04-05 |
| K890322 | SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.) | Surgical Laser Technologies, Inc. | GEX | Class II | 1989-04-05 |
| K891236 | FDX SOLID STATE VIDEO CAMERA MODEL 5950 | Medical Dynamics, Inc. | FWD | Class I | 1989-04-05 |
| K890286 | SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU) | Sharplan Lasers, Inc. | GEX | Class II | 1989-04-05 |
| K885342 | GENNY DENNY IV SHIELD | Mercury Enterprises, Inc. | FMK | Class II | 1989-03-30 |
| K891247 | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC | Siemens Hearing Instruments, Inc. | ESF | Class II | 1989-03-29 |
| K890865 | HEXASCAN SCANNER HANDPIECE | Metatech Corp. | GEX | Class II | 1989-03-24 |
| K883391 | POLYMER ADHESIVE BANDAGE | Marion Laboratories, Inc. | NAD | Class I | 1989-03-23 |
| K890973 | STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE | Instrument Makar, Inc. | JOS | Class II | 1989-03-22 |
| K891348 | CAMPION LASER FORCEPS | Simpson/Basye, Inc. | GEN | Class I | 1989-03-22 |
| K885099 | MULTIPLE (STERILE SURGICAL TOWELS) | Med-Tex, Inc. | KKX | Class II | 1989-03-22 |
| K890972 | HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE | Instrument Makar, Inc. | JOS | Class II | 1989-03-22 |
| K890820 | LOCKING WIRE GUIDE STYLET | Medical Engineering and Development Institute | GAD | Class I | 1989-03-22 |
| K885283 | ASPIRATING AND IRRIGATING CYSTS NEEDLES | Go Medical Industries Pty. , Ltd. | GDM | Class I | 1989-03-22 |
| K891088 | MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE | Sharplan Lasers, Inc. | GEX | Class II | 1989-03-17 |
| K890270 | AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 1989-03-17 |
| K891126 | MICROLASE CO2 LASER MICROMANIPULATOR | Ximed Medical Systems | GEX | Class II | 1989-03-17 |
| K890601 | STUART TITANIUM SURGICAL MESH | Stuart | EZX | Class II | 1989-03-16 |
| K890101 | FEMORAL ANGIOGRAPHY DRAPE | Medical Plastics, Inc. | KKX | Class II | 1989-03-16 |
| K884622 | SURGICAL GLOVES | Globe Ent., Inc. | KGO | Class I | 1989-03-14 |
| K890826 | SONY VIDEO GRAPHIC PRINTER UP-850 | Sony Corp. of America | KQM | Class I | 1989-03-14 |
| K890867 | TC SYSTEM-COVER | Transmedical Corp. | FTA | Class II | 1989-03-14 |
| K890709 | O.R. TOWELS (STERILE) | Cypress Medical Products, Ltd. | KKX | Class II | 1989-03-14 |
| K890771 | ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK | 3M Company | FXX | Class II | 1989-03-14 |
| K885145 | MEDSURG GREENE NEEDLE | Medsurg Industries, Inc. | DWO | Class I | 1989-03-14 |
| K890866 | TC SYSTEM-HANDLE | Transmedical Corp. | FTA | Class II | 1989-03-14 |
| K891016 | SHARPLAN MODEL 2106 | Sharplan Lasers, Inc. | GEX | Class II | 1989-03-13 |
| K890726 | TRACHEOSTOMY CARE AND CLEANING KITS | Cypress Medical Products, Ltd. | LRO | Class II | 1989-03-10 |
| K890748 | ALLEVYN TRACHEOSTOMY DRESSING | Smith & Nephew United, Inc. | NAD | Class I | 1989-03-08 |
| K890311 | KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE) | Kosan Far East Ent. , Ltd. | KGO | Class I | 1989-03-03 |
| K882643 | AM TM SYRGICAL DRAPES | Henley Intl. | KKX | Class II | 1989-03-03 |
| K890648 | MALIS BIPOLAR CORD/IRRIGATION TUBING SET | Valley Forge Scientific Corp. | GEI | Class II | 1989-03-03 |
| K883848 | KMI OXY-BAN | Knight Medical, Inc. | KPJ | Class II | 1989-03-02 |
| K890471 | PMS ANGIO DRAPE | Professional Medical Services | KKX | Class II | 1989-02-27 |
| K890539 | SURE COUNT LIGHT HANDLE COVER | Kleen Test Products | FTA | Class II | 1989-02-27 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.