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Padlock Clip-12

by Aponos Medical Corp.

510(k) K120814

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 NumberK120814 Date6 Sep 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1011-2019 FDA Class II initiated 4 Feb 2019

    Potential esophageal laceration during a patient procedure

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  • Withdrawn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
PKL
Device Class
Class II
Regulation
21 CFR Part 876.4400
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent