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Parietene PPM5050

by Sofradim Production

Parietene PPM5050 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K250869 on 23 Apr 2025 and listed in FDA GUDID since 8 Nov 2025 (UDI-DI 10884521857179), 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) K250869

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 Number10884521857179 UDI-DI Date8 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK250869 Date23 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250869 decided 23 Apr 2025 Active
  • FDA GUDID UDI-DI 10884521857179 listed 8 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250869
  2. Listed FDA GUDID 10884521857179

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Parietene
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / reference
PPM5050
Primary DI / UDI-DI
10884521857179
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
In Commercial Distribution
MRI safety
MR Safe
Size
Weight — 11.5 Gram
Width — 50 Centimeter
Length — 50 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
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)