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510(k) K872475

SURGICAL BUR by Tava Surgical Instruments — Product Code GFF

K872475 is an FDA 510(k) premarket notification submitted by Tava Surgical Instruments for the device "SURGICAL BUR". The FDA issued a decision of Substantially Equivalent on July 2, 1987. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. Tava Surgical Instruments has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1987
Date Received
June 23, 1987
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 Tava Surgical Instruments

  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)
  • K940109 — TAVA K-WIRE (February 22, 1994)
  • K885273 — MICRO SURGICAL INSTRUMENT SYSTEM (January 30, 1989)
  • K884492 — MICRO SURGICAL INSTRUMENT SYSTEM (November 16, 1988)
  • K863788 — SAWBLADE (October 14, 1986)
  • K854543 — PULSE LAVAGE (January 27, 1986)

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)
  • K862852 — MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (August 11, 1986)

FDA data resources