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ProSup TECLGK01

by Covidien LP

ProSup TECLGK01 is a Class II device made by Covidien LP, cleared under FDA 510(k) K982532 on 20 Jan 1999 and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 10884521177611), 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 found

in data synced 23 Oct 2026

Documents

510(k) K982532

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 Number10884521177611 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982532 Date20 Jan 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982532 decided 20 Jan 1999 Active
  • FDA GUDID UDI-DI 10884521177611 listed 6 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982532
  2. Listed FDA GUDID 10884521177611

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProSup
Generic name
Pelvic organ prolapse surgical mesh, synthetic polymer
Model / reference
TECLGK01
Primary DI / UDI-DI
10884521177611
510(k) Number
FDA product code
FTL
GMDN term
Pelvic organ prolapse surgical mesh, synthetic polymer
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
Size
Width — 15 Centimeter

Similar devices

Other devices filed under FDA product code FTL (Mesh, surgical, polymeric).

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)