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VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture

by Ethicon Inc.

510(k) K183183

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK183183 Date27 Jun 2019ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-1513-2025 FDA Class II initiated 7 Mar 2025 on shared 510(k) K183183

    Identified curing issues with the silicone during the needles manufacturing process.

    • Ongoing Z-0319-2025 FDA Class II initiated 25 Sep 2024

    Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

    • Ongoing Z-2146-2024 FDA Class II initiated 10 May 2024

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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