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STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

by Ethicon Inc.

510(k) K192144

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 NumberK192144 Date25 Mar 2020ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2605-2025 FDA Class II initiated 15 Aug 2025

    Potential for barb non-engagement.

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  • Withdrawn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
NEW
FDA applicant
ETHICON, Inc.
Device Class
Class II
Regulation
21 CFR Part 878.4840
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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