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Stratafix SXPN2B405

by Ethicon Inc.

Stratafix SXPN2B405 is a barbed polyolefin/fluoropolymer suture (FDA Class II; FDA product code GAW, Suture, nonabsorbable, synthetic, polypropylene) 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 10705031472938), 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 Number10705031472938 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 10705031472938 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253572
  2. Listed FDA GUDID 10705031472938

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  • Withdrawn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
SXPN2B405
Primary DI / UDI-DI
10705031472938
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)