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Parietex TCM1106

by Sofradim Production

Parietex TCM1106 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K090858 on 6 May 2009 and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 10884521178830), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K090858

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 Number10884521178830 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090858 Date6 May 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090858 decided 6 May 2009 Active
  • FDA GUDID UDI-DI 10884521178830 listed 6 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090858
  2. Listed FDA GUDID 10884521178830

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Parietex
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / reference
TCM1106
Primary DI / UDI-DI
10884521178830
510(k) Number
FDA product code
FTL
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device class
Class II
Regulation number
878.3300
GUDID distribution status
Not in Commercial Distribution
Size
Length — 11 Centimeter
Width — 6 Centimeter

Similar devices

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

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)