Atlas FDA

Endoform Reconstructive Template - PLGA

FDA 510(k) clearance K250598 · decided 2025-06-03

Clearance details

K-number
K250598
Device name
Endoform Reconstructive Template - PLGA
Applicant
Aroa Biosurgery , Ltd.
Decision
Substantially Equivalent
Date received
2025-02-28
Decision date
2025-06-03
Days to decision
95 days
Clearance type
Traditional
Product code
FTM
Device class
2
Regulation number
878.3300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Auckland, NZ
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.