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Sofsilk GSJ36M-2

by Covidien LP

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521758087 UDI-DI Date19 Jul 2020ListedStatusListed GUDID: in commercial distribution

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sofsilk
Generic Name
Silk suture
Model / Reference
GSJ36M-2
Primary DI / UDI-DI
10884521758087
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 — 18 Inch

Related devices

Category: Silk suture

Cleared under the same submission (K981128)

Show all (12)

Other devices from Covidien LP

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No