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Tenderlett Finger

by International Technidyne Corp.

510(k) K923302

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 NumberK923302 Date22 Jan 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0673-06 FDA Unclassified (pre-2012) initiated 23 Jan 2006

    Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product.

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  • Withdrawn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
FMK
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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