FDA Product Code
FDA Product Code GBX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4200
510(k) Clearances — 77 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | Moerae Matrix, Inc. | 2014-03-03 | Traditional | PDF ↗ |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | Maquet Cardiovascular, LLC | 2008-12-17 | Traditional | PDF ↗ |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | 2005-10-21 | Traditional | PDF ↗ |
| K043515 | GRAFTSAVER | Vescare, Inc. | 2005-03-31 | Traditional | PDF ↗ |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | Misonix, Inc. | 2002-01-10 | Traditional | PDF ↗ |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | 2000-05-19 | Traditional | PDF ↗ |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | 1998-02-03 | Traditional | PDF ↗ |
| K973703 | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN | Allegiance Healthcare Corp. | 1997-12-04 | Traditional | PDF ↗ |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Axiom Medical, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Sil-Med Corp. | 1996-06-26 | Traditional | PDF ↗ |
| K961147 | CLOSED FLUID COLLECTION SYSTEM | B.Braun Medical, Inc. | 1996-05-31 | Traditional | PDF ↗ |
| K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | Baxter Healthcare Corp | 1996-05-22 | Traditional | PDF ↗ |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | 1996-03-13 | Traditional | PDF ↗ |
| K955474 | NEO-PNEUMOCATH | Intra Special Catheters GmbH | 1996-02-13 | Traditional | PDF ↗ |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1996-02-07 | Traditional | PDF ↗ |
| K955439 | THE REEL THING (MODIFICATION) | Biomedical Devices, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | Sil-Med Corp. | 1995-05-24 | Traditional | PDF ↗ |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-05-15 | Traditional | PDF ↗ |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-04-24 | Traditional | PDF ↗ |
| K950439 | INSYTE SIDEHOLDED DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K950437 | ANGIOCATH SIDEHOLDER DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K942335 | ACI SILICATH THORACIC CATHETER | American Catheter | 1994-08-09 | Traditional | PDF ↗ |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | Deknatel, Inc. | 1994-07-27 | Traditional | PDF ↗ |
| K940156 | THE REEL THING | Bio-Medical Devices, Inc. | 1994-06-07 | Traditional | PDF ↗ |
| K942273 | ORION SUCTION CATHETER KIT WITH STERILE WATER | Regulatory & Marketing Services, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K942274 | ORION SUCTION CATHETER KIT WITH STERILE SALINE | Regulatory & Marketing Services, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | Puritas Health Care, Inc. | 1994-05-05 | Traditional | PDF ↗ |
| K940352 | STORZ N5941 SERIES MEDICAL GRADE TUBING | Storz Instrument Co. | 1994-04-14 | Traditional | PDF ↗ |
| K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | Navarre Biomedical , Ltd. | 1994-03-28 | Traditional | PDF ↗ |
| K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE | Sil-Med Corp. | 1994-02-02 | Traditional | PDF ↗ |
| K926408 | SIL-SLIP FLAT SUCTION DRAIN | Sil-Med Corp. | 1994-02-02 | Traditional | PDF ↗ |
| K932391 | NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET | Navarre Biomedical , Ltd. | 1994-01-27 | Traditional | PDF ↗ |
| K932205 | ERCP CATHETER, HYDROPHILIC COATED | Wilson-Cook Medical, Inc. | 1994-01-03 | Traditional | PDF ↗ |
| K925117 | URESIL ABSCESS DRIANAGE AND IRRIGATION SET | Uresil Corp. | 1993-08-11 | Traditional | PDF ↗ |
| K926109 | FLUID DRAINAGE TRAY | Symbiosis Corp. | 1993-06-07 | Traditional | PDF ↗ |
| K930551 | KENDALL UNIVERSAL EXTENSION SET | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-05-12 | Traditional | PDF ↗ |
| K923667 | IRRIGATION/SUCTION PROBE | Surgical Instrument, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K925176 | VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE | Boston Scientific Corp | 1993-04-08 | Traditional | PDF ↗ |
| K925805 | KENDALL WOUND DRAINAGE SYSTEMS-TROCARS | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-26 | Traditional | PDF ↗ |
| K925748 | KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-01-13 | Traditional | PDF ↗ |
| K924702 | TURKEL ABDOMINAL PARACENTESIS SYSTEM | Symbiosis Corp. | 1993-01-12 | Traditional | PDF ↗ |
| K925533 | ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET | Angeion Corp. | 1993-01-12 | Traditional | PDF ↗ |
| K921424 | SIL-MED FLAT SUCTION DRAIN | Sil-Med Corp. | 1992-09-28 | Traditional | PDF ↗ |
| K922739 | HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE | Hollister, Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K921934 | INTRADUCER | Taut, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K921095 | PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT | Pacer Tool & Plastics, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K913539 | THORACIC CATHTER STYLET | Intl. Medical Devices , Ltd. | 1992-01-21 | Traditional | PDF ↗ |
| K913542 | THORACIC CATHETER WITH GUIDE | Intl. Medical Devices , Ltd. | 1992-01-21 | Traditional | PDF ↗ |
| K910245 | I/A HANDPIECE WITH REPLACEABLE TIPS | Surgical Technologies, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K905614 | JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS | Baxter Healthcare Corp | 1991-03-20 | Traditional | PDF ↗ |
| K905766 | DRAINAGE TUBE RESTRAINT/WOUND COVER | M. Imonti and Associates Inc., | 1991-03-06 | Traditional | PDF ↗ |
| K905422 | PVC ROUND WOUND DRAINS | Axiom Medical, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | Axiom Medical, Inc. | 1990-10-11 | Traditional | PDF ↗ |
| K895756 | MIKRO-AQUAPURATOR | Mikro-Tek Laboratories | 1989-12-27 | Traditional | PDF ↗ |
| K895755 | MIKRO-LAVAGE-1 | Mikro-Tek Laboratories | 1989-12-27 | Traditional | PDF ↗ |
| K895516 | CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 | Arrow Intl., Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K895757 | IRRI-EVACUATOR | Mikro-Tek Laboratories | 1989-10-19 | Traditional | PDF ↗ |
| K883474 | THORACIC CATHETERS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-09-13 | Traditional | PDF ↗ |
| K870704 | CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET | American Pharmaseal Div. Ahsc | 1987-03-27 | Traditional | PDF ↗ |
| K844809 | CONTINUOUS VENTILATOR | Hamilton Medical, Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K852143 | HALL IRRIGATION SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1985-06-26 | Traditional | PDF ↗ |
| K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, | Pennine Medical , Ltd. | 1985-06-05 | Traditional | PDF ↗ |
| K844061 | MICROTEK IRRIGATION SYSTEM | Microtek Medical, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K851475 | VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 | Vygon Corp. | 1985-05-03 | Traditional | PDF ↗ |
| K844922 | PERIMETER THORACIC CATHETER | Perimeter Medical, Inc. | 1985-03-18 | Traditional | PDF ↗ |
| K844094 | PRUITT IRRIGATION AND OCCLUSION CATHETER | Bionomy, Inc. | 1984-11-29 | Traditional | PDF ↗ |
| K843617 | SDC SILICONE SUMP DRAIN | Science Development Corp. | 1984-10-24 | Traditional | PDF ↗ |
| K841362 | TIDAL DISTENSION IRRIGATION SET | Abbott Laboratories | 1984-08-02 | Traditional | PDF ↗ |
| K840323 | SILICONE SUCTION & IRRIGATION DRAIN | Superior Plastic Products Corp. | 1984-04-25 | Traditional | PDF ↗ |
| K830859 | I/A KIT | Surgeon Surgical Instrumentation, Inc. | 1983-05-02 | Traditional | PDF ↗ |
| K823496 | ARTHROSCOPIC IRRIGATION SETS-2C4030/31 | Travenol Laboratories, S.A. | 1982-12-28 | Traditional | PDF ↗ |
| K822510 | SUCTION CATHETER W/STERILE WATER | Medine Dynacor | 1982-10-13 | Traditional | PDF ↗ |
| K780788 | IRRIGATION CATHETER | Shiley, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K771079 | CURITY IRRIGATION TRAY | Kendall Research Center | 1977-09-15 | Traditional | PDF ↗ |
| K770706 | CATHETER, IRRIGATION | Mallinckrodt Critical Care | 1977-05-06 | Traditional | PDF ↗ |
| K770442 | SUMP DRAIN, W/FILTER, ARGYLE EDLICH | Sherwood Medical Industries | 1977-03-30 | Traditional | PDF ↗ |
Product code GBX · Class I · General, Plastic Surgery. Data: openFDA.