GBX — Catheter, Irrigation Class I
FDA product code GBX covers "Catheter, Irrigation", a Class I medical device regulated under 21 CFR 878.4200. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GBX
- Device Class
- Class I
- Regulation Number
- 878.4200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131659 | moerae matrix | MOERAE VEIN PREPARATION KIT | March 3, 2014 |
| K082725 | maquet cardiovascular | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | December 17, 2008 |
| K052286 | catheter exchange | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | October 21, 2005 |
| K043515 | vescare | GRAFTSAVER | March 31, 2005 |
| K013417 | misonix | MISONIX IRRIGATION SYSTEM MOEDL BC20P | January 10, 2002 |
| K000704 | dmc medical | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | May 19, 2000 |
| K974233 | lysonix | LYSONIX IRRIGATION SYSTEM | February 3, 1998 |
| K973703 | allegiance healthcare | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN | December 4, 1997 |
| K972635 | ultracell medical technologies | ULTRACELL SUCTION SPONGE | October 1, 1997 |
| K965146 | axiom medical | FLAT CLOSED WOUND DRAIN WITH TROCAR | March 10, 1997 |
| K961295 | sil-med | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | June 26, 1996 |
| K961147 | b.braun medical | CLOSED FLUID COLLECTION SYSTEM | May 31, 1996 |
| K960955 | baxter healthcare | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | May 22, 1996 |
| K955339 | northgate technologies | HYDROLOGY 5000 | March 13, 1996 |
| K955474 | intra special catheters | NEO-PNEUMOCATH | February 13, 1996 |
| K955505 | navarre biomedical | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | February 7, 1996 |
| K955439 | biomedical devices | THE REEL THING (MODIFICATION) | December 26, 1995 |
| K926496 | sil-med | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | May 24, 1995 |
| K951907 | navarre biomedical | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | May 15, 1995 |
| K951475 | navarre biomedical | NAVARRE UNIVERSAL DRAINAGE CATHETER | April 24, 1995 |