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GBS — Catheter, Ventricular, General & Plastic Surgery Class I

FDA Device Classification

Classification Details

Product Code
GBS
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
K912645atrium medicalATRIUMS PDR THORACIC CATHETERSeptember 13, 1991
K883887axiomAXIOM ATRAUM WOUND DRAINSFebruary 17, 1989
K881873sheridan catheterINTRODUCTION/DRAINAGE CATHETER & ACCESSMay 18, 1988
K880895uresilURESIL WOUND DRAIN TROCARMarch 14, 1988
K880376genesis industriesNOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPFebruary 16, 1988
K873377gish biomedicalCLOSED CHEST DRAINAGE SET W/SUTURESOctober 28, 1987
K872460h.w. andersen productsAN3000 MAHONEY DRAINJuly 23, 1987
K872459h.w. andersen productsAN3100 MULHOLLAND DRAINJuly 21, 1987
K872457h.w. andersen productsAN3500 WORTH DRAINJuly 21, 1987
K870015health care innovationsHCI ALL PURPOSE DRAIN/CATHETER SETFebruary 6, 1987
K863560uresilURESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRASeptember 29, 1986
K863142sheridan catheterTHORACIC CATHETER (CHEST DRAINAGE TUBE)August 29, 1986
K863247axiom medicalAXIOM TROCAR THORACIC CATHETERAugust 29, 1986
K862584treace medicalOSTEOTOMY DRAINAGE TUBEAugust 12, 1986
K862767sil-medSILICONE SUMP DRAINAugust 7, 1986
K854418sil-medROUND SUCTION DRAINNovember 19, 1985
K853131j. h. emersonTHORO/CATH STRAIGHT THORACIC RIGHT ANGLESeptember 5, 1985
K852241axiom medicalAXIOM ATRAUM TROCAR CATHETERJune 14, 1985
K851048medovationsCHEST CATHETERS/THORACIC CATHETERSJune 5, 1985
K843906snyder laboratoriesSNYDER HEMOVAC WOUND DRAINAGE DEVICESNovember 5, 1984