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Ti-Cron CD-3123K

by Covidien LP

Ti-Cron CD-3123K is a Class II device made by Covidien LP, cleared under FDA 510(k) K930591 on 17 Dec 1993 and listed in FDA GUDID since 31 Aug 2015 (UDI-DI 10884521063037), active as of 23 Oct 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 ongoing

6 closed

Documents

510(k) K930591

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 Number10884521063037 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK930591 Date17 Dec 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K930591 decided 17 Dec 1993 Active
  • FDA GUDID UDI-DI 10884521063037 listed 31 Aug 2015 Listed

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2827-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2826-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2830-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2825-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2828-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2829-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591

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

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

Timeline

8 dated events

  1. Cleared FDA 510(k) K930591
  2. Recall initiated FDA recalls Z-2827-2011
  3. Recall initiated FDA recalls Z-2826-2011
  4. Recall initiated FDA recalls Z-2830-2011
  5. Recall initiated FDA recalls Z-2825-2011
  6. Recall initiated FDA recalls Z-2828-2011
  7. Recall initiated FDA recalls Z-2829-2011
  8. Listed FDA GUDID 10884521063037

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ti-Cron
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / reference
CD-3123K
Primary DI / UDI-DI
10884521063037
510(k) Number
FDA product code
GAT
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
Size
Length — 18 Inch

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K930591)

and 8 more cleared under K930591

Similar devices in this category

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

Other devices from Covidien LP

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    Class II

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    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)