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Plug T5 PT50-S

by Herniamesh

Plug T5 PT50-S is a Class II device made by Herniamesh, cleared under FDA 510(k) K973955 on 11 May 1998 and listed in FDA GUDID since 8 Jan 2018 (UDI-DI 58032919891193), 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) K973955

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 Number58032919891193 UDI-DI Date8 Jan 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973955 Date11 May 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973955 decided 11 May 1998 Active
  • FDA GUDID UDI-DI 58032919891193 listed 8 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973955
  2. Listed FDA GUDID 58032919891193

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plug T5
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / reference
PT50-S
Primary DI / UDI-DI
58032919891193
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

Related devices

Cleared under the same submission (K973955)

and 8 more cleared under K973955

Similar devices

Other devices filed under FDA product code FTL (Mesh, Surgical, Polymeric).

Other devices from Herniamesh

  • Hermesh H41515

    Class II

  • Plug T2 PT2/3

    Class II

  • Hermesh H60611

    Class II

  • Hermesh H40815

    Class II

See all devices from Herniamesh →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)