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510(k) K950449

SURGICAL BUR by Transidyne General Corp. — Product Code GFF

K950449 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "SURGICAL BUR". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. Transidyne General Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
February 3, 1995
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 Transidyne General Corp.

  • K961217 — BODILY FLUID DISPOSAL KIT (July 25, 1996)
  • K955658 — LACERATION TRAY (January 25, 1996)
  • K950743 — ORAL PROCEDURE PACK (March 31, 1995)
  • K950773 — PROPHYLAXIS PACK (March 31, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K924811 — I.V. START KIT (June 17, 1993)
  • K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)
  • K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)
  • K897133 — MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT (March 30, 1990)

Other clearances for product code GFF

  • K974025 — ANSPACH SHIELDED ATTACHMENT (July 6, 1998)
  • 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)
  • K862852 — MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (August 11, 1986)

FDA data resources