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Stratafix SXPN2B403

by Ethicon Inc.

Stratafix SXPN2B403 is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K253572 on 27 Mar 2026 and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 10705031472914), active as of 9 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

510(k) K253572

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031472914 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253572 Date27 Mar 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253572 decided 27 Mar 2026 Active
  • FDA GUDID UDI-DI 10705031472914 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253572
  2. Listed FDA GUDID 10705031472914

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stratafix
Generic name
Barbed polyolefin/fluoropolymer suture
Model / Ref / Catalog
SXPN2B403
Primary DI / UDI-DI
10705031472914
510(k) Number
FDA product code
GAW
GMDN term
Barbed polyolefin/fluoropolymer suture
Device class
Class II
Regulation number
878.5010
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K253572)

and 8 more cleared under K253572

Similar devices

Other devices filed under FDA product code GAW (Suture, nonabsorbable, synthetic, polypropylene).

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)