GEC — Brush, Scrub, Operating-Room Class I

FDA Device Classification

Classification Details

Product Code
GEC
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
K971473m-pact worldwide managementIVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKJuly 7, 1997
K960621shippert medical technologiesEXPANDACELL INSTRUMENT WIPEApril 1, 1996
K900691bio-dyneBIODYNE INSTRUMENT WIPESMarch 8, 1990
K896085sparta surgicalSURGI-BRUSHNovember 8, 1989
K875033medsurg industriesSTERILE SCRUBBY SCRUB BRUSHFebruary 19, 1988
K875129absorbent cotton coSTERI-CLENSFebruary 18, 1988
K872823pacific biosystemsDELTA SCRUBJanuary 7, 1988
K874653surgikosSTERILE SURGICAL SCRUB BRUSHDecember 30, 1987
K874741absorbent cotton coSTERI-CLENS(TM) SURGICAL SCRUB SPONGEDecember 10, 1987
K870258k. w. griffenBIOSCRUB SURGICAL SCRUB BRUSHFebruary 24, 1987
K854232american pharmaseal div. ahscPHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGESDecember 10, 1985
K844411american sterilizerSCRUB MATE DRY STERILE SCRUB BRUSHDecember 17, 1984
K843636ballard medical productsFOAM CARE ONE STEP PREPNovember 16, 1984
K831488minnetonkaDAVRON PROF. SCRUB BRUSH-DRY/STERILEJune 8, 1983
K831226ballard medical productsMEDICAL PRODUCTS FOAM DOUBLE SCRUB #450May 16, 1983
K830393h and p industriesPROVIDONE-IODINE SWABSTICKSApril 6, 1983
K830394h and p industriesPROVIDONE-IODINE PREP-PADS & TOWELETTESApril 6, 1983
K823173buckeye celluloseARRIRM SCRUB BRUSH/SPONGENovember 22, 1982
K823061seamless hospital productsBRUSH, SCRUB, OPERATING ROOMNovember 5, 1982
K822865acme unitedSURGI-SCRUB VOctober 18, 1982