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510(k) K821485

DERMABRADERS by Spire Medical, Inc. — Product Code GFF

K821485 is an FDA 510(k) premarket notification submitted by Spire Medical, Inc. for the device "DERMABRADERS". The FDA issued a decision of Substantially Equivalent on June 10, 1982. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. Spire Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1982
Date Received
May 18, 1982
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 by Spire Medical, Inc.

  • K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS. (July 2, 1982)
  • K821486 — MICRO DRILLS (June 9, 1982)
  • K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)
  • K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)

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)
  • K883255 — KOMET SURGICAL BUR (September 15, 1988)
  • K880859 — SURGICAL BURS (March 21, 1988)
  • K880706 — SURGICAL BURS (February 26, 1988)
  • K872475 — SURGICAL BUR (July 2, 1987)

FDA data resources