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EFQ — Gauze/Sponge, Internal Class U

FDA Device Classification

FDA product code EFQ covers "Gauze/Sponge, Internal", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EFQ
Device Class
Class U
Regulation Number
Submission Type
Review Panel
SU
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K991757Furlong IndustriesNON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEAug 12, 1999
K991215Symtex HealthcareSYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SJun 11, 1999
K990974Wonder And Bioenergy Hi-Tech AmericaVITOP DRESSINGJun 9, 1999
K990584Broadline Medical IndustriesGAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEApr 23, 1999
K984187Crosstex IntlCROSSTEX NON-WOVEN SPONGESFeb 18, 1999
K983016Vitalcare GroupGAUZE, SPONGES, CAT # 11-003Feb 12, 1999
K983348DynarexDYNAREX TRACHEOSTOMY SPONGEDec 11, 1998
K983450T.C. Dental ProductsSTARRYSHINE GAUZE SPONGENov 12, 1998
K982648Celanese AcetateJOAN IISep 30, 1998
K980791Dumex Medical Surgical ProductsDUMEX PAK-ITS WOVEN RIBBON PACKINGApr 29, 1998
K974316HydroferaHYDROFERA FEMORAL WICKFeb 13, 1998
K974347Baldur SystemsBALDUR NON-STERILE COTTON SPONGESFeb 10, 1998
K973763Kendall Healthcare Products Co. Div.Of Tyco HealthKENDALL CURITY IODOFORM PACKING STRIPDec 31, 1997
K973580Invotec InternationalINVOTEC CLEAN PADDec 10, 1997
K973299Brown Medical IndustriesPIN CARE KITNov 26, 1997
K971095OpportunityOPPORTUNITY SUTURE REMOVAL KITSep 16, 1997
K971088OpportunityOPPORTUNITY INCISION AND DRAINAGE TRAYSep 16, 1997
K971178Trans AireRAND SURGICAL SPONGEJun 27, 1997
K971075Primeline Medical ProductsPRIMED PRIME-PLUS COTTON GAUZE SPONGESJun 22, 1997
K970457DukalDUKAL ABD COMBINE PADMay 8, 1997

FDA data resources