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Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design

by Surgical Specialties Corp. Dba Angiotech 3 variants

510(k) K122898

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK122898 Date22 Oct 2012ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1053-2022 FDA Class II initiated 24 Mar 2022

    Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

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  • Withdrawn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
GAM
Device Class
Class II
Regulation
21 CFR Part 878.4493
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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