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Polycryl A6409

by Aurolab

Polycryl A6409 is a Class II device made by Aurolab, cleared under FDA 510(k) K140039 on 15 Sep 2014 and listed in FDA GUDID since 12 Dec 2020 (UDI-DI 00803878029032), active as of 22 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 22 Oct 2026

Documents

510(k) K140039

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00803878029032 UDI-DI Date12 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140039 Date15 Sep 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140039 decided 15 Sep 2014 Active
  • FDA GUDID UDI-DI 00803878029032 listed 12 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140039
  2. Listed FDA GUDID 00803878029032

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Polycryl
Generic name
Nylon suture, non-bioabsorbable, monofilament
Model / reference
A6409
Primary DI / UDI-DI
00803878029032
510(k) Number
FDA product code
GAM
GMDN term
Nylon suture, non-bioabsorbable, monofilament
Device class
Class II
Regulation number
878.4493
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nylon suture, non-bioabsorbable, monofilament

Cleared under the same submission (K140039)

and 3 more cleared under K140039

Similar devices in this category

Other devices filed under Nylon suture, non-bioabsorbable, monofilament.

Other devices from Aurolab

See all devices from Aurolab →

Properties

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