Home / 510(k) Clearances / K162554

510(k) K162554

Gentrix Surgical Matrix by Acell, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
September 13, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Acell, Inc.

  • K241706 — MicroMatrix® UBM Particulate (July 11, 2024)
  • K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix (July 11, 2024)
  • K230980 — MicroMatrix® Flex (September 22, 2023)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K192725 — Cytal Wound Matrix 3-Layer (October 25, 2019)
  • K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (February 7, 2019)
  • K180776 — Cytal Wound Particulate (May 11, 2018)
  • K172399 — MicroMatrix (October 6, 2017)
  • K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (June 8, 2017)
  • K153754 — MicroMatrix (March 14, 2016)

Other clearances for product code FTM

  • K250598 — Endoform Reconstructive Template - PLGA (June 3, 2025)
  • K243595 — OviTex PRS (Long-Term Resorbable) (December 19, 2024)
  • K233991 — CanGaroo RM Antibacterial Envelope (June 14, 2024)
  • K241126 — OviTex PRS (May 22, 2024)
  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K214070 — OviTex PRS (Long Term Resorbable) (March 21, 2023)
  • K213163 — VersaWrap (October 29, 2021)
  • K213125 — PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU (October 27, 2021)
  • K203496 — Nexo-Gide Bilayer Collagen Membrane (July 14, 2021)
  • K203600 — VersaWrap (March 9, 2021)