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Aurosilk B6105

by Aurolab

Aurosilk B6105 is a Class II device made by Aurolab, cleared under FDA 510(k) K024091 on 28 Feb 2003 and listed in FDA GUDID since 23 Jun 2020 (UDI-DI 00803878029087), 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) K024091

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 Number00803878029087 UDI-DI Date23 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024091 Date28 Feb 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024091 decided 28 Feb 2003 Active
  • FDA GUDID UDI-DI 00803878029087 listed 23 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K024091
  2. Listed FDA GUDID 00803878029087

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aurosilk
Generic name
Silk suture
Model / reference
B6105
Primary DI / UDI-DI
00803878029087
510(k) Number
FDA product code
GAP
GMDN term
Silk suture
Device class
Class II
Regulation number
878.5030
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Silk suture.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains latex
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)