GFF — Bur, Surgical, General & Plastic Surgery Class I

FDA Device Classification

Classification Details

Product Code
GFF
Device Class
Class I
Regulation Number
878.4820
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K974025anspach effortANSPACH SHIELDED ATTACHMENTJuly 6, 1998
K950449transidyne generalSURGICAL BURMarch 1, 1995
K943758komet medicalSURGICAL BURAugust 22, 1994
K934583american medical specialtiesBURRSJanuary 26, 1994
K894438micro-aire surgical instrumentsMICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSAugust 21, 1989
K890090danek medicalDANEK IRRIGATING BURR (DIB) SETJanuary 24, 1989
K883255komet medical, div. of brasseler usa i, l.pKOMET SURGICAL BURSeptember 15, 1988
K880859new england surgical instrumentSURGICAL BURSMarch 21, 1988
K880706nuell air equipment and hospital suppliesSURGICAL BURSFebruary 26, 1988
K872475tava surgical instrumentsSURGICAL BURJuly 2, 1987
K862852micro-aire surgical instrumentsMICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTRAugust 11, 1986
K853658acumed instrumentsBURS FOR MICRO SURGICAL DRILL SYSTEMSeptember 24, 1985
K850497micro-aire surgical instrumentsMICRO-AIRE GENERIC BURS & DRILLSMarch 1, 1985
K841298techmedicaHOLE CHAMFERING DEVICEApril 25, 1984
K821485spire medicalDERMABRADERSJune 10, 1982
K820281micro-aire surgical instrumentsMICRO-AIRE REPLACEMENT DRILL BURSFebruary 23, 1982