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GDY — Gauze/Sponge, Internal, X-Ray Detectable Class I

FDA Device Classification

Classification Details

Product Code
GDY
Device Class
Class I
Regulation Number
878.4450
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972634ultracell medical technologiesULTRACELL SUCTION SPONGEDecember 17, 1997
K960236custom pack reliabilityCPR LAP SPONGESMarch 28, 1996
K955599strykerSTRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEFebruary 22, 1996
K955322derivados de gasa, s.a. de c.vPROTEC X-RAY DETECTABLE GAUZE SPONGEDecember 19, 1995
K953830kentron health careKENSORBOctober 3, 1995
K953060medical perspectivesROSEBUD DISSECTORSeptember 14, 1995
K953088medical perspectivesTRIANGULAR SPONGESSeptember 14, 1995
K953062medical perspectivesCHERRY DISSECTORSeptember 14, 1995
K953059medical perspectivesKITTNER DISSECTORSeptember 14, 1995
K953057medical perspectivesCYLINDRICAL SPONGESeptember 14, 1995
K953087medical perspectivesCHERRY PIT DISSECTORSeptember 14, 1995
K953058medical perspectivesROUND STICK SPONGES, FLAT STICK SPONGESSeptember 14, 1995
K951911commercial resources new mexicoGAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)June 21, 1995
K950373ultracell medical technologiesULTRACELL ORTHOPEDIC SPONGESApril 17, 1995
K950372ultracell medical technologiesULTRACELL ORTHOPEDIC SPONGESApril 17, 1995
K950370ultracell medical technologiesULTRACELL ORTHOPEDIC SPONGESApril 17, 1995
K950659ultracell medical technologiesULTRACELL RETRACTOR COVERSApril 13, 1995
K945333lorrex health productsKITTNER DISSECTORDecember 28, 1994
K945606lorrex health productsTRIANGULAR SPONGESDecember 28, 1994
K945866lorrex health productsCYLINDRICAL SPONGEDecember 28, 1994