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)
Berkeley Advanced Biomaterials · Unknown
Open FDA's page for this record- Third party flag
- N
- City
- Berkeley
- Advisory committee description
- Unknown
- Address 1
- 2800 Seventh St.
- Statement or summary
- Summary
- Product code
- KGN
- Zip code
- 94710
- Applicant
- Berkeley Advanced Biomaterials
- Decision date
- 2026-10-22
- Decision code
- SESE
- Country code
- US
- Contact
- Bradley Glover
- K number
- K260920
- State
- CA
- Date received
- 2026-03-19
- Review advisory committee
- SU
- Postal code
- 94710
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
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)
- Harmonized identifiers (openFDA)
- Device name
- Wound Dressing With Animal-Derived Material(S)
- Medical specialty description
- Unknown
- Device class
- U
- Registration number
- 3043861816, 1720734, 3010097129, 8043792, 3015058854, 3017399129, 3010824458, 1645368, 3042750477, 3030067857, 1650372, 2530154, 3015282703, 2431866, 3002636527, 3016429246, 3027448274, 2030598, 3013820501, 9680579, 2245539, 1066741, 2249852, 1648579, 3014498807, 3012448339, 3014146451, 1225991, 3012535730, 3007738736, 3039169663, 3006802076, 8043396, 1417592, 3004431266, 3010187826, 3010155661, 1531062, 1835959, 3007663067 +102 more
- FEI number
- 3043861816, 1720734, 3010097129, 3015058854, 3017399129, 3000303710, 3010824458, 1000208624, 3002808269, 3042750477, 1000138377, 3030067857, 1000148471, 3015282703, 2431866, 3003015552, 3016429246, 3027448274, 3002636527, 3008162665, 3013820501, 3002924544, 3002340648, 2245539, 3002253367, 3014498807, 3012448339, 1000137528, 3014146451, 3012535730, 3007738736, 3039169663, 3006802076, 3004431266, 1417592, 3010187826, 3010155661, 1000307073, 3007663067, 3004189237 +102 more