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GBX — Catheter, Irrigation Class I

FDA Device Classification

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-NumberApplicantDevice NameDate
K131659moerae matrixMOERAE VEIN PREPARATION KITMarch 3, 2014
K082725maquet cardiovascularGRAFTGUARD PRESSURE CONTROLLING SYRINGEDecember 17, 2008
K052286catheter exchangeDEUTSCH ANTI-BLOCKAGE WOUND DRAINOctober 21, 2005
K043515vescareGRAFTSAVERMarch 31, 2005
K013417misonixMISONIX IRRIGATION SYSTEM MOEDL BC20PJanuary 10, 2002
K000704dmc medicalDMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)May 19, 2000
K974233lysonixLYSONIX IRRIGATION SYSTEMFebruary 3, 1998
K973703allegiance healthcareJACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAINDecember 4, 1997
K972635ultracell medical technologiesULTRACELL SUCTION SPONGEOctober 1, 1997
K965146axiom medicalFLAT CLOSED WOUND DRAIN WITH TROCARMarch 10, 1997
K961295sil-medSAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCARJune 26, 1996
K961147b.braun medicalCLOSED FLUID COLLECTION SYSTEMMay 31, 1996
K960955baxter healthcareJACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATINGMay 22, 1996
K955339northgate technologiesHYDROLOGY 5000March 13, 1996
K955474intra special cathetersNEO-PNEUMOCATHFebruary 13, 1996
K955505navarre biomedicalOPTI-DRAIN MULTI-USE DRAINAGE CATHETERFebruary 7, 1996
K955439biomedical devicesTHE REEL THING (MODIFICATION)December 26, 1995
K926496sil-medSIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAINMay 24, 1995
K951907navarre biomedicalNAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETERMay 15, 1995
K951475navarre biomedicalNAVARRE UNIVERSAL DRAINAGE CATHETERApril 24, 1995