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Permacol P100510

by Sofradim Production

Permacol P100510 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K120605 on 18 May 2012 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 10884523000092), 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) K120605

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 Number10884523000092 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120605 Date18 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120605 decided 18 May 2012 Active
  • FDA GUDID UDI-DI 10884523000092 listed 16 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120605
  2. Listed FDA GUDID 10884523000092

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Permacol
Generic name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Model / reference
P100510
Primary DI / UDI-DI
10884523000092
510(k) Number
FDA product code
FTM
GMDN term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
Size
Width — 5 Centimeter
Length — 10 Centimeter
Depth — 1 Millimeter

Related devices

Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Cleared under the same submission (K120605)

and 8 more cleared under K120605

Similar devices

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

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)