Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 36
- Latest Decision
- 1993-05-17
Clearances · page 113 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | Medical Devices, Inc. | FWF | Class I | 1993-05-17 |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | GCY | Class I | 1993-05-17 |
| K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | Elmed, Inc. | GEI | Class II | 1993-05-17 |
| K924943 | ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY | Cardiogenes | GEX | Class II | 1993-05-17 |
| K924713 | UNIVERSAL SURGICAL INSTRUMENT HOLDER | T. Korossurgical Instruments Corp. | FWW | Class I | 1993-05-17 |
| K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | Alto Development Corp. | GEI | Class II | 1993-05-17 |
| K925830 | MICROSURGE SUCTION/IRRIGATION SYSTEM | Microsurge, Inc. | GEI | Class II | 1993-05-17 |
| K930551 | KENDALL UNIVERSAL EXTENSION SET | Kendall Healthcare Products Co. Div.Of Tyco Health | GBX | Class I | 1993-05-12 |
| K925426 | RIZZO NASAL IMPLANT | Implantech Associates, Inc. | FZE | Class II | 1993-05-12 |
| K925841 | HYDRASORB JOYCE SPONGE | Avitar, Inc. | NAC | Class I | 1993-05-12 |
| K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | Ndm Corp. | NAE | Class I | 1993-05-12 |
| K925715 | RS OPTIGUARD GOWN & DRAPE MATERIAL | Baxter Healthcare Corp | FYA | Class II | 1993-05-11 |
| K923229 | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE | Medical Armor Corp. | LYU | Class I | 1993-05-07 |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | GAA | Class I | 1993-05-07 |
| K924457 | MICROMANIPULATOR | Laser Engineering, Inc. | GEX | Class II | 1993-05-07 |
| K926036 | ACUFEX SUTURE RETRIEVER | Acufex Microsurgical, Inc. | GAE | Class I | 1993-05-05 |
| K925005 | ISI SELF-SUPPORTING ARM | Instrumentation Specialties, Inc. | BWN | Class I | 1993-04-29 |
| K930361 | ASI CYSTOLASE LASER CYSTOSCOPE | Advanced Surgical Intervention, Inc. | GEX | Class II | 1993-04-29 |
| K925016 | PREP SHAVE KIT (NON-STERILE) | Customed, Inc. | LRO | Class II | 1993-04-26 |
| K930210 | ACL-5500 | Ilt Systems, Inc. | GEX | Class II | 1993-04-23 |
| K930775 | DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC | Falcon Instruments, Inc. | MDM | Class I | 1993-04-23 |
| K924424 | UNIMEDIX HOLMIUM FIBER | Unimedix, Inc. | GEX | Class II | 1993-04-23 |
| K926415 | VALLEYLAB CURRENT MONITOR, E3350 & E3351 | Valleylab, Inc. | GEI | Class II | 1993-04-23 |
| K923667 | IRRIGATION/SUCTION PROBE | Surgical Instrument, Inc. | GBX | Class I | 1993-04-23 |
| K924160 | HYBRID SURGICAL DEVICE | Lca, Inc. | GEX | Class II | 1993-04-23 |
| K913566 | ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM | Alfred O. Bonati, M.D. | GEX | Class II | 1993-04-20 |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | GAA | Class I | 1993-04-20 |
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Unisurge, Inc. | GDO | Class I | 1993-04-20 |
| K925708 | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | Beacon Laboratories, Inc. | DWG | Class II | 1993-04-20 |
| K924976 | ALLKARE(TM) ADHESIVE REMOVER WIPE | Convatec, A Division of E.R. Squibb & Sons | KOX | Class I | 1993-04-20 |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | GEI | Class II | 1993-04-16 |
| K925266 | SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES | Laser Surgical Systems | GEI | Class II | 1993-04-15 |
| K924664 | SURGILASE FIBERLASE CO2 LASER WAVEGUIDE | Surgilase, Inc. | GEX | Class II | 1993-04-15 |
| K925590 | MULTI-TRAUMA DRESSING | Gam Industries, Inc. | NAB | Class I | 1993-04-08 |
| K925176 | VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE | Boston Scientific Corp | GBX | Class I | 1993-04-08 |
| K922935 | CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Buckman Co., Inc. | GEX | Class II | 1993-04-07 |
| K924469 | GRASPERS & SCISSORS (MINIMAL ACCESS SURG INSTR) | Conmedcorp | GEI | Class II | 1993-04-07 |
| K922577 | CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | GEX | Class II | 1993-04-07 |
| K930159 | OPTICON(TM) CONNECTOR ADAPTER | Xintec Corporation | GEX | Class II | 1993-04-07 |
| K924283 | MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS | Microsurge, Inc. | GEI | Class II | 1993-04-07 |
| K924537 | LPI ML210 HOLMIUM SURGICAL LASER | Laser Photonics, Inc. | GEX | Class II | 1993-04-07 |
| K924571 | MEDI-SOL | Orange-Sol, Inc. | KOX | Class I | 1993-04-06 |
| K924981 | OPERATIVE CHOLANGIOGRAM CATHETER | Taut, Inc. | GBZ | Class I | 1993-04-06 |
| K925875 | HORIZONTAL NEEDLE GUIDE ATTACHMENT | Bip USA, Inc. | GDF | Class I | 1993-04-06 |
| K923274 | ZEISS VISULAS DIODE LASER | Carl Zeiss, Inc. | GEX | Class II | 1993-04-05 |
| K924524 | FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE EXTENDER | Valleylab, Inc. | GEI | Class II | 1993-04-05 |
| K920334 | LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. | Laser Photonics, Inc. | GEX | Class II | 1993-03-31 |
| K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX | 3M Health Care, Ltd. | KOX | Class I | 1993-03-31 |
| K923191 | SWITCHABLE TIP SYSTEM | Trimedyne, Inc. | GEX | Class II | 1993-03-31 |
| K922919 | DYNACYT BIOPSY ASPIRATION DEVICE | Buckman Co., Inc. | MJG | Class I | 1993-03-31 |
| K923991 | ZOE LASER, CONTACT ND:YAG LASER SYSTEM | Lca, Inc. | GEX | Class II | 1993-03-31 |
| K930490 | SLT MULTIDIMENSIONAL CONTACT LASER SYST A4060C | Surgical Laser Technologies, Inc. | GEX | Class II | 1993-03-31 |
| K923815 | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS | Laivan Corp. | FYA | Class II | 1993-03-31 |
| K924094 | MEND APC | Mend Technologies, Inc. | JEA | Class I | 1993-03-30 |
| K922127 | HOSPITAL KIT GP 103 | Savoy Medical Supply Co., Inc. | MDM | Class I | 1993-03-29 |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Savoy Medical Supply Co., Inc. | MDM | Class I | 1993-03-26 |
| K920629 | QUINEVAC II | Recto Molded Products, Inc. | FYD | Class II | 1993-03-24 |
| K920819 | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | GCY | Class I | 1993-03-24 |
| K920628 | QUINEVAC EVACUATOR/ASPIRATOR | Recto Molded Products, Inc. | BTA | Class II | 1993-03-23 |
| K923600 | ENDO OPTIKS VALUE PACK | Endo Optics, Inc. | LRO | Class II | 1993-03-23 |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | KDD | Class I | 1993-03-23 |
| K920267 | DYONICS ARTHROSCOPIC KIT | Smith & Nephew Dyonics, Inc. | LRO | Class II | 1993-03-23 |
| K922962 | VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE | Cameo, Inc. | KKX | Class II | 1993-03-23 |
| K922961 | VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS, | Cameo, Inc. | KKX | Class II | 1993-03-23 |
| K922128 | HOSPITAL KIT EP 104 | Savoy Medical Supply Co., Inc. | MDM | Class I | 1993-03-23 |
| K924834 | PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) | American Healthcare Supply Co., Inc. | MCZ | Class I | 1993-03-23 |
| K924835 | VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 | American Healthcare Supply Co., Inc. | MCZ | Class I | 1993-03-23 |
| K923233 | CARDIO-PAK LAPAROTOMY PACK | Cardio-Med-Associates, Inc. | FZH | Class II | 1993-03-20 |
| K922648 | ACE CUSTOM SURGICAL PACK | Ace Surgical Supply Co., Inc. | LRO | Class II | 1993-03-20 |
| K922213 | LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK | Trimedyne, Inc. | GEX | Class II | 1993-03-20 |
| K926072 | K-BAND AND K-CREPE | Parema , Ltd. | NAB | Class I | 1993-03-19 |
| K924120 | MOLDED FIBER CAP DELIVERY SYSTEM | Lca, Inc. | GEX | Class II | 1993-03-19 |
| K924223 | MAR-MED LIVER STRAP | Mar-Med Co. | GDJ | Class I | 1993-03-18 |
| K925130 | NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) | Laserscope | GEI | Class II | 1993-03-18 |
| K921657 | VASECTOMY DRAPE | Graham Medical Products | KKX | Class II | 1993-03-18 |
| K925874 | BREAST STABILIZER | Bip USA, Inc. | MDM | Class I | 1993-03-16 |
| K925549 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Sunrise Technologies, Inc. | GEX | Class II | 1993-03-09 |
| K922753 | COMPEL XTR | Standard Textile Co., Inc. | FYA | Class II | 1993-03-09 |
| K926225 | SPONGE COUNTER | American Medical Manufacturer, Inc. | FWZ | Class I | 1993-03-05 |
| K920346 | VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL | Trinity Laboratories, Inc. | KKX | Class II | 1993-03-03 |
| K924480 | CHOLANGIOGRAPHY CLAMP | Applied Medical Resources | GBZ | Class I | 1993-03-03 |
| K922059 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Graham Medical Products | KKX | Class II | 1993-03-03 |
| K925150 | MODIFIED ARTICULATING ENDOSCOPIC CLAMP | United States Medical Corp. | GEI | Class II | 1993-02-26 |
| K910825 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. | Pfizer Laser Systems | GEX | Class II | 1993-02-26 |
| K925989 | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | Kendall Healthcare Products Co. Div.Of Tyco Health | GCY | Class I | 1993-02-26 |
| K925805 | KENDALL WOUND DRAINAGE SYSTEMS-TROCARS | Kendall Healthcare Products Co. Div.Of Tyco Health | GBX | Class I | 1993-02-26 |
| K924644 | ENDOSTATS, MICROSTATS, ACCUSTATS | Laserscope | GEX | Class II | 1993-02-23 |
| K923811 | COMPEL SURGICAL DRAPES | Standard Textile Co., Inc. | KKX | Class II | 1993-02-23 |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | GAA | Class I | 1993-02-23 |
| K924969 | PHOTOTHERAPY TIMER | National Biological Corp. | FTC | Class II | 1993-02-23 |
| K920808 | OB/GYN DRAPE | Preferred Medical Products | KKX | Class II | 1993-02-19 |
| K925035 | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | FWZ | Class I | 1993-02-18 |
| K923170 | LOS ALAMOS RETRACTABLE KNIFE | Innovative Surgical Technology, Inc. | GES | Class I | 1993-02-18 |
| K921889 | COMPEL O AND R | Standard Textile Co., Inc. | FYA | Class II | 1993-02-18 |
| K921549 | DORNIER FIBERTOME 100 WATT SURGICAL LASER | Dornier Medtech America, Inc. | GEX | Class II | 1993-02-18 |
| K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER | O.R. Concepts, Inc. | MDM | Class I | 1993-02-17 |
| K922949 | SURGICAL GOWN | Robert J. Sislian, Inc. | FYA | Class II | 1993-02-16 |
| K925148 | AUTO SUTURE SURGICAL MESH DEPLOYER | United States Surgical, A Division of Tyco Healthc | FTL | Class II | 1993-02-12 |
| K923929 | PERRY POWDER-FREE GLOVES, STYLE 45G | Smith & Nephew Perry | KGO | Class I | 1993-02-10 |
| K922288 | HOLDER, PEDIATRIC POSITION | Yamashita and Hemsley Business Trust | BWN | Class I | 1993-02-10 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.