Product code GBX
- Device name
- Catheter, Irrigation
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | Moerae Matrix, Inc. | 2014-03-03 |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | Maquet Cardiovascular, LLC | 2008-12-17 |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | 2005-10-21 |
| K043515 | GRAFTSAVER | Vescare, Inc. | 2005-03-31 |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | Misonix, Inc. | 2002-01-10 |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | 2000-05-19 |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | 1998-02-03 |
| K973703 | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN | Allegiance Healthcare Corp. | 1997-12-04 |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Axiom Medical, Inc. | 1997-03-10 |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Sil-Med Corp. | 1996-06-26 |
| K961147 | CLOSED FLUID COLLECTION SYSTEM | B.Braun Medical, Inc. | 1996-05-31 |
| K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | Baxter Healthcare Corp | 1996-05-22 |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | 1996-03-13 |
| K955474 | NEO-PNEUMOCATH | Intra Special Catheters GmbH | 1996-02-13 |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1996-02-07 |
| K955439 | THE REEL THING (MODIFICATION) | Biomedical Devices, Inc. | 1995-12-26 |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | Sil-Med Corp. | 1995-05-24 |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-05-15 |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-04-24 |
| K950437 | ANGIOCATH SIDEHOLDER DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-03-14 |
| K950439 | INSYTE SIDEHOLDED DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-03-14 |
| K942335 | ACI SILICATH THORACIC CATHETER | American Catheter | 1994-08-09 |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | Deknatel, Inc. | 1994-07-27 |
| K940156 | THE REEL THING | Bio-Medical Devices, Inc. | 1994-06-07 |
| K942273 | ORION SUCTION CATHETER KIT WITH STERILE WATER | Regulatory & Marketing Services, Inc. | 1994-06-02 |
| K942274 | ORION SUCTION CATHETER KIT WITH STERILE SALINE | Regulatory & Marketing Services, Inc. | 1994-06-02 |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | Puritas Health Care, Inc. | 1994-05-05 |
| K940352 | STORZ N5941 SERIES MEDICAL GRADE TUBING | Storz Instrument Co. | 1994-04-14 |
| K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | Navarre Biomedical , Ltd. | 1994-03-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08034139294629 | Round Drain type Jackson-Pratt Fr 7 | REDAX SPA | 2021-05-07 |
| 08034139294599 | Flat Drain type Jackson-Pratt w/trocar 4x13 mm | REDAX SPA | 2021-05-07 |
| 08034139294582 | Flat Drain type Jackson-Pratt 4x13 mm | REDAX SPA | 2021-05-07 |
| 08034139294575 | Flat Drain type Jackson-Pratt w/trocar 4x10 mm | REDAX SPA | 2021-05-07 |
| 08034139294568 | Flat Drain type Jackson-Pratt 4x10 mm | REDAX SPA | 2021-05-07 |
| 08034139292823 | Thoracic Catheter, Straight Fr 18 | REDAX SPA | 2021-05-07 |
| 08034139292830 | Thoracic Catheter, Straight Fr 21 | REDAX SPA | 2021-05-07 |
| 08034139292847 | Thoracic Catheter, Straight Fr 24 | REDAX SPA | 2021-05-07 |
| 08034139292861 | Thoracic Catheter, Straight Fr 30 | REDAX SPA | 2021-05-07 |
| 08034139292878 | Thoracic Catheter, Straight Fr 33 | REDAX SPA | 2021-05-07 |
| 08034139294544 | Flat Drain 3/4 type Jackson-Pratt 4x10 mm | REDAX SPA | 2021-05-07 |
| 08034139293813 | Thoracic Catheter, Angled Fr 33 | REDAX SPA | 2021-05-07 |
| 08034139293806 | Thoracic Catheter, Angled Fr 30 | REDAX SPA | 2021-05-07 |
| 08034139294513 | Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar | REDAX SPA | 2021-05-05 |
| 08034139294636 | Round Drain type Jackson-Pratt Fr 7 w/trocar | REDAX SPA | 2021-05-05 |
| 08034139294520 | Flat Drain type Jackson-Pratt 3x7 mm | REDAX SPA | 2021-05-05 |
| 08034139294537 | Flat Drain type Jackson-Pratt 3x7 mm w/trocar | REDAX SPA | 2021-05-05 |
| 08034139294551 | Flat Drain 3/4 type Jackson-Pratt 4x10 mm w/trocar | REDAX SPA | 2021-05-05 |
| 08034139293820 | Thoracic Catheter, Angled Fr 36 | REDAX SPA | 2021-05-05 |
| 08034139293790 | Thoracic Catheter, Angled Fr 28 | REDAX SPA | 2021-05-05 |
| 08034139293783 | Thoracic Catheter, Angled Fr 24 | REDAX SPA | 2021-05-05 |
| 08034139292885 | Thoracic Catheter, Straight Fr 36 | REDAX SPA | 2021-05-05 |
| 08034139292854 | Thoracic Catheter, Straight Fr 28 | REDAX SPA | 2021-05-05 |
| 08034139292816 | Thoracic Catheter, Straight Fr 15 | REDAX SPA | 2021-05-05 |
| 08034139292809 | Thoracic Catheter, Straight Fr 12 | REDAX SPA | 2021-05-04 |
| 08034139294506 | Flat Drain type Jackson-Pratt 3x7 mm | REDAX SPA | 2021-05-03 |
| 07613327381450 | N/A | STRYKER CORPORATION | 2018-09-23 |
| 07613327381443 | N/A | STRYKER CORPORATION | 2018-09-23 |
| 07613327381436 | N/A | STRYKER CORPORATION | 2018-09-23 |
| 07613327381429 | N/A | STRYKER CORPORATION | 2018-09-23 |