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Surgical Bur

by Tava Surgical Instruments

510(k) K872475

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872475 Date2 Jul 1987ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0591-2020 FDA Class II initiated 18 Oct 2019

    One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GFF
Device Class
Class I
Regulation
21 CFR Part 878.4820
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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