Skip to content

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device

by Ethicon Inc.

510(k) K192580

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 NumberK192580 Date18 Dec 2019ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1533-2024 FDA Class II initiated 8 Mar 2024

    Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

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  • Withdrawn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

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →