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Hermesh H90611

by Herniamesh

Hermesh H90611 is a Class II device made by Herniamesh, cleared under FDA 510(k) K973955 on 11 May 1998 and listed in FDA GUDID since 13 Oct 2021 (UDI-DI 58032919892244), 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) 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 Number58032919892244 UDI-DI Date13 Oct 2021ListedStatusListed GUDID: 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 58032919892244 listed 13 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973955
  2. Listed FDA GUDID 58032919892244

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hermesh
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / reference
H90611
Primary DI / UDI-DI
58032919892244
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

Similar devices in this category

Other devices filed under Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

Other devices from Herniamesh

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    Class II
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  • Hermesh H60611

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  • 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)