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Coaptite Laryngeal Augmentation System 1cc & O.5CC, Models 0008021-1, 0008022-1

by Bioform, Inc.

510(k) K013243

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 NumberK013243 Date9 Jan 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0368-2016 FDA Class II initiated 26 Oct 2015

    The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

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  • Withdrawn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
KHJ
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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