GES — Blade, Scalpel Class I

FDA Device Classification

Classification Details

Product Code
GES
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
K032242omi manufacturing ptyPERSONNA PLUS SAFETY SCALPEL SYSTEMSeptember 23, 2003
K932998devon industriesEASY-ONAugust 18, 1993
K923170innovative surgical technologyLOS ALAMOS RETRACTABLE KNIFEFebruary 18, 1993
K915119intergrated visualSCALPEL BLADE REMOVER (BLADEGARD)May 5, 1992
K911913bd becton dickinson vacutainer systems preanalyticPRECISION GLIDE - ENHANCED SURGICAL BLADEMay 13, 1991
K900266rahn laboratoriesSTERILE CARBON STEEL SURGICAL BLADEMarch 1, 1990
K884862anchor productsANCHOR DOUBLE-EDGE MYRINGOTOMY BLADEDecember 27, 1988
K881638far east intl. tradingSURGICAL BLADEJune 15, 1988
K880244ailee c/o havelSURGICAL BLADESFebruary 10, 1988
K873493primrose medicalNINJA SCALPELSeptember 24, 1987
K873142american safety razorPERSONNA DISPOSABLE SCALPELSeptember 4, 1987
K863885sable industriesSABLE BLADESOctober 24, 1986
K863867storz instrumentDEXTRA DISPOSABLE BLADESOctober 24, 1986
K863214keisei medical industrial coKEISEI MICRO-BLADES (STERILE AND NON-STERILE)September 2, 1986
K863211keisei medical industrial coKEISEI SURGICAL BLADES (STERILE & NON-STERILE)September 2, 1986
K855104angiomed u.sANGIOMED SKIN FASCIA KNIFEJanuary 24, 1986
K854860medelec intlBLADES, SCALPEL CARBON STEETDecember 24, 1985
K854859medelec intlBLADES, SCALPEL STAINLESS STEELDecember 24, 1985
K854620niraj industriesSURGICAL BLADESDecember 17, 1985
K854561medelec intlBLADE, SCALPELDecember 2, 1985