Skip to content

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices

by Ethicon Inc.

510(k) K182873

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK182873 Date10 Jan 2019ClearedStatusActive

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1335-2020 FDA Class II initiated 28 Aug 2019
    • Terminated Z-1334-2020 FDA Class II initiated 28 Aug 2019
    • Terminated Z-1336-2020 FDA Class II initiated 28 Aug 2019

    The product do not meet certain internal testing specifications.

  • 2 recalls, same reason

    • Terminated Z-0047-2020 FDA Class II initiated 13 Aug 2019
    • Terminated Z-0048-2020 FDA Class II initiated 13 Aug 2019

    The product does not meet certain internal strength testing specifications.

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  • Withdrawn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

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →