Skip to content

Atramat Polipropileno

by Internacional Farmacéutica S.A DE C.V 125 variants

Atramat Polipropileno (CE2463-75) is a Class II device made by Internacional Farmacéutica S.A DE C.V, cleared under FDA 510(k) K911189 on 25 Apr 1991 and listed in FDA GUDID since 4 Jul 2018 (UDI-DI 07500142000386), 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) K911189

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 Number07500142000386 UDI-DI Date4 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK911189 Date25 Apr 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K911189 decided 25 Apr 1991 Active
  • FDA GUDID UDI-DI 07500142000386 listed 4 Jul 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K911189
  2. Listed FDA GUDID 07500142000386

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  • Withdrawn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
Polyolefin/fluoropolymer suture, monofilament
Model / Ref / Catalog
POLIPROPILENO, CE2463-75
Primary DI / UDI-DI
07500142000386
510(k) Number
FDA product code
GAW
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class II
Regulation number
878.5010
GUDID distribution status
In Commercial Distribution
Size
Length — 24 Millimeter

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Cleared under the same submission (K911189)

and 8 more cleared under K911189

Similar devices in this category

Other devices filed under Polyolefin/fluoropolymer suture, monofilament.

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
  • Implantable
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)