Home / 510(k) Clearances / K883255

510(k) K883255

KOMET SURGICAL BUR by Komet Medical, Div. of Brasseler USA I, L.P. — Product Code GFF

K883255 is an FDA 510(k) premarket notification submitted by Komet Medical, Div. of Brasseler USA I, L.P. for the device "KOMET SURGICAL BUR". The FDA issued a decision of Substantially Equivalent on September 15, 1988. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1988
Date Received
August 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances for product code GFF

  • K974025 — ANSPACH SHIELDED ATTACHMENT (July 6, 1998)
  • K950449 — SURGICAL BUR (March 1, 1995)
  • K943758 — SURGICAL BUR (August 22, 1994)
  • K934583 — BURRS (January 26, 1994)
  • K894438 — MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS (August 21, 1989)
  • K890090 — DANEK IRRIGATING BURR (DIB) SET (January 24, 1989)
  • K880859 — SURGICAL BURS (March 21, 1988)
  • K880706 — SURGICAL BURS (February 26, 1988)
  • K872475 — SURGICAL BUR (July 2, 1987)
  • K862852 — MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (August 11, 1986)

FDA data resources