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Ethibond Excel D8253

by Ethicon Inc.

Ethibond Excel D8253 is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K946173 on 9 Jan 1995 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10705031029651), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

510(k) K946173

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031029651 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK946173 Date9 Jan 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K946173 decided 9 Jan 1995 Active
  • FDA GUDID UDI-DI 10705031029651 listed 1 Sep 2015 Listed

Recalls

10 recalls · 5 ongoing · FDA

    • Ongoing Z-0284-2027 FDA Not yet classified initiated 23 Sep 2026

    Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.

    • Ongoing Z-0153-2027 FDA Class II initiated 8 Sep 2026

    Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.

    • Ongoing Z-1516-2025 FDA Class II initiated 7 Mar 2025 on shared 510(k) K946173

    Identified curing issues with the silicone during the needles manufacturing process.

    • Ongoing Z-1097-2025 FDA Class II initiated 20 Dec 2024 on shared 510(k) K946173

    Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

    • Ongoing Z-2486-2020 FDA Class II initiated 10 Jun 2020 on shared 510(k) K946173

    Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years

  • 2 recalls, same reason

    • Terminated Z-1841-2019 FDA Class II initiated 19 Apr 2019
    • Terminated Z-1842-2019 FDA Class II initiated 19 Apr 2019

    Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

    • Terminated Z-0747-2019 FDA Class II initiated 18 Dec 2018 on shared 510(k) K946173

    The sutures inside the packaging are not the same size or type as indicated on the label.

    • Terminated Z-1839-2015 FDA Class II initiated 8 May 2015 on shared 510(k) K946173

    Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.

    • Terminated Z-0492-2015 FDA Class II initiated 17 Oct 2014 on shared 510(k) K946173

    Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-1839-2015
  2. Listed FDA GUDID 10705031029651
  3. Recall initiated FDA recalls Z-0747-2019
  4. Recall initiated FDA recalls Z-1841-2019
  5. Recall initiated FDA recalls Z-1842-2019
  6. Recall initiated FDA recalls Z-2486-2020
  7. Recall initiated FDA recalls Z-1097-2025
  8. Recall initiated FDA recalls Z-1516-2025
  9. Recall initiated FDA recalls Z-0153-2027
  10. Recall initiated FDA recalls Z-0284-2027

2 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ethibond Excel
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
D8253
Primary DI / UDI-DI
10705031029651
510(k) Number
FDA product code
GAT, GAQ
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.5000, 878.4495
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K946173)

and 8 more cleared under K946173

Similar devices in this category

Other devices filed under Polyester suture, non-bioabsorbable, multifilament.

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)