Home / 510(k) Clearances / K260920

510(k) K260920

Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA) by Berkeley Advanced Biomaterials — Product Code KGN

K260920 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials for the device "Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA)". The FDA issued a decision of Substantially Equivalent on Oct 22, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Berkeley Advanced Biomaterials has 15 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 22, 2026
Date Received
Mar 19, 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
Review Panel
SU
Submission Type
510(k)

Other clearances by Berkeley Advanced Biomaterials

  • K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix… (Aug 27, 2026)
  • K170917 — Bi-Ostetic Bioactive Glass Foam (Oct 30, 2017)
  • K113791 — B-GENIN, R-GENIN (Mar 15, 2012)
  • K091912 — B-GENIN AND R-GENIN (Jun 23, 2010)
  • K092046 — BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY (Mar 24, 2010)
  • K053213 — BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (Jul 6, 2006)
  • K051914 — GENEROS 80, GENEROS 60 (Nov 3, 2005)
  • K051695 — MARROW PLUS (M+) (Jul 19, 2005)
  • K050666 — GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G… (Apr 11, 2005)
  • K042636 — BIOPLUS (Dec 14, 2004)

Other clearances for product code KGN

  • K260530 — epi-ConneKt™ Wound Matrix (Oct 15, 2026)
  • K260652 — ColActive Plus (Sep 9, 2026)
  • K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix… (Aug 27, 2026)
  • K260596 — Collagen Wound Powder (Jul 2, 2026)
  • K260669 — Endoform Dermal Template (Jun 24, 2026)
  • K253521 — ECMT-100 WMD (Jun 18, 2026)
  • K253204 — Catalyze (Jun 5, 2026)
  • K253974 — Roosin Collagen Dressing (Jun 3, 2026)
  • K254034 — Roosin Collagen Powder (Jun 3, 2026)
  • K261224 — MatriDerm (May 14, 2026)

FDA data resources

Source: FDA 510(k) database entry for K260920. Report a data issue: hello@regdatalab.com.