Skip to content

Sofsilk CS-424

by Covidien LP

Sofsilk CS-424 is a Class II device made by Covidien LP, cleared under FDA 510(k) K981128 on 11 May 1998 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10884521083653), active as of 23 Oct 2026. 13 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

3 ongoing

This device is named in the recall

Documents

510(k) K981128

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 Number10884521083653 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK981128 Date11 May 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K981128 decided 11 May 1998 Active
  • FDA GUDID UDI-DI 10884521083653 listed 1 Sep 2015 Listed

Recalls

13 recalls · 3 ongoing · FDA

    • Ongoing Z-1697-2024 FDA Class II initiated 25 Jan 2024

    One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.

    • Ongoing Z-0845-2024 FDA Class II initiated 21 Dec 2023

    Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

    • Ongoing Z-1176-2023 FDA Class II initiated 2 Dec 2022

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

  • 10 recalls, same reason

    • Terminated Z-2810-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2813-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2815-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2811-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2818-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2812-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2816-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2814-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2817-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011
    • Terminated Z-2819-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011

    Potential for the sterile barrier to be breached compromising the sterility of the product

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-2818-2011
  2. Recall initiated FDA recalls Z-2812-2011
  3. Recall initiated FDA recalls Z-2816-2011
  4. Recall initiated FDA recalls Z-2814-2011
  5. Recall initiated FDA recalls Z-2817-2011
  6. Recall initiated FDA recalls Z-2819-2011
  7. Listed FDA GUDID 10884521083653
  8. Recall initiated FDA recalls Z-1176-2023
  9. Recall initiated FDA recalls Z-0845-2024
  10. Recall initiated FDA recalls Z-1697-2024

5 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
Sofsilk
Generic name
Silk suture
Model / reference
CS-424
Primary DI / UDI-DI
10884521083653
510(k) Number
FDA product code
GAP
GMDN term
Silk suture
Device class
Class II
Regulation number
878.5030
GUDID distribution status
In Commercial Distribution
Size
Length — 30 Inch

Related devices

Category: Silk suture

Cleared under the same submission (K981128)

and 8 more cleared under K981128

Similar devices in this category

Other devices filed under Silk suture.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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