# Aroa Biosurgery Limited (Formerly Mesynthes Limited)

- Location (FDA's records): Auckland, NZ
- FDA decisions: 3 (2016–2016): 3 510(k) clearances
- Names in FDA's records: Aroa Biosurgery Limited (Formerly Mesynthes Limited) (2); Aroa Biosurgery (Formerly Mesynthes Limited) (1)
- Product codes: FTM (2), FTL (1)
- 510(k) review time since 2016: median 109 days, against 88 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Biotech, Inc.: 2 (https://510kreport.com/company/cook-biotech)
- Mesynthe, Ltd.: 1 (https://510kreport.com/company/mesynthe)
- TELA Bio, Inc.: 1 (https://510kreport.com/company/tela-bio)

## Firms that cite its devices most
- Aroa Biosurgery, Ltd.: 2 (https://510kreport.com/company/aroa-biosurgery)

## Its most-cited devices
- K153633: Endoform Reconstructive Template (2016), cited by 1
- K153632: Endoform Reconstructive Template (2016), cited by 1

## Recent decisions
- K162461: Endoform Plastics and Reconstructive Matrix (Dec 20, 2016)
- K153632: Endoform Reconstructive Template (Jun 16, 2016)
- K153633: Endoform Reconstructive Template (Mar 15, 2016)

Source page: https://510kreport.com/company/aroa-biosurgery-formerly-mesynthes