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Atramat PGC25

by Internacional Farmacéutica S.A DE C.V 64 variants

Atramat PGC25 (HPE1903-B) is a Class II device made by Internacional Farmacéutica S.A DE C.V, cleared under FDA 510(k) K072863 on 23 May 2008 and listed in FDA GUDID since 13 Jul 2018 (UDI-DI 07500142057021), 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) K072863

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 Number07500142057021 UDI-DI Date13 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK072863 Date23 May 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072863 decided 23 May 2008 Active
  • FDA GUDID UDI-DI 07500142057021 listed 13 Jul 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K072863
  2. Listed FDA GUDID 07500142057021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Atramat
Generic name
Poliglecaprone suture
Model / Ref / Catalog
PGC25, HPE1903-B
Primary DI / UDI-DI
07500142057021
510(k) Number
FDA product code
GAM
GMDN term
Poliglecaprone suture
Device class
Class II
Regulation number
878.4493
GUDID distribution status
In Commercial Distribution
Size
Length — 19 Millimeter

Related devices

Category: Poliglecaprone suture

Cleared under the same submission (K072863)

and 8 more cleared under K072863

Similar devices

Other devices filed under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Other devices from Internacional Farmacéutica S.A DE C.V

  • Atramat Seda

    Class II

  • Atramat Poliester

    Class II

  • Atramat Pga

    Class II

  • Atramat Nylon

    Class II

See all devices from Internacional Farmacéutica S.A DE C.V →

Properties

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