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AceConnex™ PSF141100-6

by Allosource

AceConnex™ PSF141100-6 is a Class II device made by Allosource, cleared under FDA 510(k) K213046 on 27 Jun 2023 and listed in FDA GUDID since 8 Nov 2023 (UDI-DI 00810053078686), 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) K213046

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 Number00810053078686 UDI-DI Date8 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213046 Date27 Jun 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213046 decided 27 Jun 2023 Active
  • FDA GUDID UDI-DI 00810053078686 listed 8 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213046
  2. Listed FDA GUDID 00810053078686

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AceConnex™
Generic name
Cadaveric-donor fascia allograft
Model / Ref / Catalog
PSF141100-6
Primary DI / UDI-DI
00810053078686
510(k) Number
FDA product code
GAT
GMDN term
Cadaveric-donor fascia allograft
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
Size
Length — 100 Millimeter
Outer Diameter — 5.5 Millimeter

Related devices

Category: Cadaveric-donor fascia allograft

Cleared under the same submission (K213046)

and 1 more cleared under K213046

Similar devices

Also classified as Cadaveric-donor fascia allograft.

Similar devices

Other devices filed under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Other devices from Allosource

See all devices from Allosource →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • HCT/P
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (7, all answered No)