NAB — Gauze / Sponge,Nonresorbable For External Use Class I

FDA Device Classification

Classification Details

Product Code
NAB
Device Class
Class I
Regulation Number
878.4014
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K946015ivalonIVALON EXTERNAL SPONGEFebruary 27, 1995
K940755isolyerISOLYER (4X4, 8PLY)May 2, 1994
K931610omni mfgOMNISORB II, NONWOVEN SPONGE, STERILE AND NONJune 24, 1993
K925590gam industriesMULTI-TRAUMA DRESSINGApril 8, 1993
K926072paremaK-BAND AND K-CREPEMarch 19, 1993
K915591eagle medicalSTERILE GAUZE PADSJanuary 27, 1993
K924650dav-mar medical productsGAUZE SPONGESJanuary 11, 1993
K923602winfield laboratoriesABSORBENT PAD -- MODIFICATIONDecember 7, 1992
K923115hermitage hospital productsCLINISORBNovember 23, 1992
K923378e.w.aUSP TYPE VII GAUZE SPONGESOctober 6, 1992
K923116hermitage hospital productsCOMBINE II WETPROOF PADOctober 6, 1992
K923846medical action industriesBURN DRESSINGSeptember 11, 1992
K921227courtaulds fibersTENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGEMay 29, 1992
K915821kerma medical productsMULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZESMay 29, 1992
K920282trinity laboratoriesPRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLEMay 29, 1992
K920269cal west tradingEZ GAUZE SPONGEApril 22, 1992
K915822kerma medical productsMULTIPLE DRESSING, STERILE NONADDHERENT PADSMarch 26, 1992
K914604molnlycke clinical productsMEPITEL NON-ADHERENT SILICONE DRESSINGMarch 25, 1992
K914842cal west tradingGAUZE BANDAGE ROLLDecember 4, 1991
K914937kerma medical productsSTERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHESDecember 4, 1991