Skip to content

Aurolon 8402N

by Aurolab

Aurolon 8402N is a Class II device made by Aurolab, cleared under FDA 510(k) K024090 on 28 Feb 2003 and listed in FDA GUDID since 20 Jun 2020 (UDI-DI 00803878028875), 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) K024090

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 Number00803878028875 UDI-DI Date20 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024090 Date28 Feb 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024090 decided 28 Feb 2003 Active
  • FDA GUDID UDI-DI 00803878028875 listed 20 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K024090
  2. Listed FDA GUDID 00803878028875

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aurolon
Generic name
Nylon suture, non-bioabsorbable, monofilament
Model / reference
8402N
Primary DI / UDI-DI
00803878028875
510(k) Number
FDA product code
GAR
GMDN term
Nylon suture, non-bioabsorbable, monofilament
Device class
Class II
Regulation number
878.5020
GUDID distribution status
In Commercial Distribution

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)