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Polysorb CL-42-MG

by Covidien LP

Polysorb CL-42-MG is a Class II device made by Covidien LP, cleared under FDA 510(k) K981935 on 25 Jun 1998 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10884521040717), active as of 23 Oct 2026. 2 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

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521040717 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK981935 Date25 Jun 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K981935 decided 25 Jun 1998 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521040717 listed 1 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2601-2018 FDA Class II initiated 15 Jun 2018

    Potential proplylene glycol contamination

    • Terminated Z-2541-2017 FDA Class II initiated 3 May 2017

    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Timeline

5 dated events

  1. Cleared FDA 510(k) K963253
  2. Cleared FDA 510(k) K981935
  3. Listed FDA GUDID 10884521040717
  4. Recall initiated FDA recalls Z-2541-2017
  5. Recall initiated FDA recalls Z-2601-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Polysorb
Generic name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / reference
CL-42-MG
Primary DI / UDI-DI
10884521040717
510(k) Number
FDA product code
GAM
GMDN term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.4493
GUDID distribution status
In Commercial Distribution
Size
Length — 18 Inch

Related devices

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Cleared under the same submission (K963253)

and 8 more cleared under K963253

Cleared under the same submission (K981935)

and 8 more cleared under K981935

Similar devices in this category

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

Other devices from Covidien LP

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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)