# Aroa Biosurgery, Ltd.

- Location (FDA's records): Mangere, NZ
- FDA decisions: 10 (2017–2026): 10 510(k) clearances
- Names in FDA's records: Aroa Biosurgery , Ltd. (8); Aroa Biosurgery (2)
- Product codes: KGN (4), FTM (2), NPL (1), FRO (1), FTL (1), BTA (1)
- 510(k) review time since 2016: median 138 days, against 174 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mesynthes, Ltd.: 3 (https://510kreport.com/company/mesynthes)
- Aroa Biosurgery Limited (Formerly Mesynthes Limited): 2 (https://510kreport.com/company/aroa-biosurgery-formerly-mesynthes)
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)
- Tei Biosciences, Inc.: 1 (https://510kreport.com/company/tei-biosciences)
- Somavac Medical Solutions, Inc.: 1 (https://510kreport.com/company/somavac-medical-solutions)

## Firms that cite its devices most
- TELA Bio, Inc.: 2 (https://510kreport.com/company/tela-bio)
- Lacerta Life Science: 1 (https://510kreport.com/company/lacerta-life-science)
- Stimlabs, LLC: 1 (https://510kreport.com/company/stimlabs)

## Its most-cited devices
- K183398: Endoform Restella (2019), cited by 2
- K200413: Symphony (2020), cited by 1
- K171231: Endoform Topical Matrix (2017), cited by 1
- K200502: Myriad Particles (2021), cited by 1

## Recent decisions
- K260669: Endoform Dermal Template (Jun 24, 2026)
- K250598: Endoform Reconstructive Template - PLGA (Jun 3, 2025)
- K231305: Endoform Dental Membrane (Jan 23, 2024)
- K223373: Enivo™ (Apr 7, 2023)
- K200502: Myriad Particles (Mar 31, 2021)
- K200413: Symphony (Jul 29, 2020)
- K183398: Endoform Restella (Apr 11, 2019)
- K181935: Endoform Reconstructive Template - Non Absorbable (Dec 4, 2018)

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