Cleared Traditional

K260711 - Accelagen Plus Surgical Matrix, 1cc (CG-01AP)

Also marketed or referenced as:
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)
K260711 · Berkeley Advanced Biomaterials · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
175d
Days
-
Risk

K260711 is an FDA 510(k) clearance for the Accelagen Plus Surgical Matrix, 1cc (CG-01AP). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Berkeley Advanced Biomaterials (Berkeley, US). The FDA issued a Cleared decision on August 27, 2026 after a review of 175 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Berkeley Advanced Biomaterials devices

FDA 510(k) Submission Details - K260711

510(k) Number K260711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2026
Decision Date August 27, 2026
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K260711.
Collagen Wound Powder
K260596 · Ventris Medical · Jul 2026
Endoform Dermal Template
K260669 · Aroa Biosurgery , Ltd. · Jun 2026
ECMT-100 WMD
K253521 · Ecm Therapeutics, Inc. · Jun 2026
Catalyze
K253204 · BioTissue Holdings, Inc. · Jun 2026
Roosin Collagen Dressing
K253974 · Roosin Medical Co., Ltd. · Jun 2026
Roosin Collagen Powder
K254034 · Roosin Medical Co., Ltd. · Jun 2026