Home / 510(k) Clearances / K213046

510(k) K213046

AceConnex Pre-Sutured Fascia by Allosource — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2023
Date Received
September 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Allosource

  • K170957 — ReConnex Pre-Sutured Tendon (March 20, 2018)
  • K103036 — ALLOFUSE PLUS (January 10, 2011)
  • K071849 — ALLOFUSE GEL AND PUTTY (December 4, 2008)

Other clearances for product code GAT

  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)