Home / 510(k) Clearances / K260711

510(k) K260711

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) by Berkeley Advanced Biomaterials — Product Code KGN

K260711 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials for the device "Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Berkeley Advanced Biomaterials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2026
Date Received
March 5, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Berkeley Advanced Biomaterials

  • K170917 — Bi-Ostetic Bioactive Glass Foam (October 30, 2017)
  • K113791 — B-GENIN, R-GENIN (March 15, 2012)
  • K091912 — B-GENIN AND R-GENIN (June 23, 2010)
  • K092046 — BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY (March 24, 2010)
  • K053213 — BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (July 6, 2006)
  • K051914 — GENEROS 80, GENEROS 60 (November 3, 2005)
  • K051695 — MARROW PLUS (M+) (July 19, 2005)
  • K050666 — GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, (April 11, 2005)
  • K042636 — BIOPLUS (December 14, 2004)
  • K041889 — TRI-OSTETIC (August 19, 2004)

Other clearances for product code KGN

  • K260652 — ColActive Plus (September 9, 2026)
  • K260596 — Collagen Wound Powder (July 2, 2026)
  • K260669 — Endoform Dermal Template (June 24, 2026)
  • K253521 — ECMT-100 WMD (June 18, 2026)
  • K253204 — Catalyze (June 5, 2026)
  • K253974 — Roosin Collagen Dressing (June 3, 2026)
  • K254034 — Roosin Collagen Powder (June 3, 2026)
  • K261224 — MatriDerm (May 14, 2026)
  • K260532 — Derma-Gide (March 19, 2026)
  • K260218 — LacertaMatrix (February 19, 2026)

FDA data resources