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FSM — Tray, Surgical, Instrument Class I

FDA Device Classification

Classification Details

Product Code
FSM
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K971217general hospital supplyINSTRUMENT TRAY LINERMay 6, 1997
K962328medcare medical groupSINGLE USE INSTRUMENT TRAYAugust 9, 1996
K944025riley medicalSURGICAL INSTRUMENT TRAYNovember 22, 1994
K912106medical device inspection coARTHROSCOPY TRAYAugust 29, 1991
K912053medical device inspection coOPEN HEART TRAYAugust 26, 1991
K912052medical device inspection coHEART CATH TRAYAugust 20, 1991
K912104medical device inspection coMAJOR BASIN TRAYAugust 9, 1991
K910570solan scissors salesSPLINTER TWEEZERSMay 31, 1991
K911601ideal medicalREDDICK TROCAR AND CANNULAMay 21, 1991
K910328key surgicalKEY COMFORT GRIPSMarch 6, 1991
K905682richard-allan medicalRICHARD-ALLAN CLAMP COVERSFebruary 19, 1991
K900376pmtHAND SURGERY AND IRRIGATION TRAY (MODEL 3625)April 10, 1990
K894610l h m entCUSTOM TRAYS, KITSMarch 15, 1990
K900479busse hospital disposablesSTERILE LACERATION TRAY CAT. #749February 13, 1990
K895527quantitative technologiesTHE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEMOctober 6, 1989
K883125terray manufacturingCASF STERILIZATION TRAYAugust 10, 1988
K883193terray manufacturingCASF STERILIZATION TRAYAugust 10, 1988
K882617brevetBREVET CASSETTE STERILIZATION MODULEJuly 28, 1988
K871924arthropedicsSTERILIZATION TRAY, TMJ INSTRUMENT SETJune 1, 1987
K871478procedure pakSURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYSMay 7, 1987