Aroa Biosurgery , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Aroa Biosurgery , Ltd.” (first 2017, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 132 days. Since 2017 the median was 132 days, against 170 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 78 |
| 2018 | 1 | 138 |
| 2019 | 1 | 125 |
| 2020 | 1 | 161 |
| 2021 | 1 | 397 |
| 2022 | 0 | — |
| 2023 | 1 | 154 |
| 2024 | 1 | 263 |
| 2025 | 1 | 95 |
| 2026 | 1 | 114 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aroa Biosurgery , Ltd. took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 170 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 4 | 4 |
| FTM | Mesh, Surgical | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
Review panels
Most recent Aroa Biosurgery , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260669 | Endoform Dermal Template | KGN | 2026-06-24 | 114 |
| K250598 | Endoform Reconstructive Template - PLGA | FTM | 2025-06-03 | 95 |
| K231305 | Endoform Dental Membrane | NPL | 2024-01-23 | 263 |
| K223373 | Enivo | BTA | 2023-04-07 | 154 |
| K200502 | Myriad Particles | KGN | 2021-03-31 | 397 |
| K200413 | Symphony | KGN | 2020-07-29 | 161 |
| K183398 | Endoform Restella | FTM | 2019-04-11 | 125 |
| K181935 | Endoform Reconstructive Template - Non Absorbable | FTL | 2018-12-04 | 138 |
| K172318 | Endoform Silver Dermal Template | FRO | 2017-11-17 | 108 |
| K171231 | Endoform Topical Matrix | KGN | 2017-06-14 | 48 |
Recalls
24 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-11-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aroa Biosurgery Limited (Formerly Mesynthes Limited) (2 510(k)s)
- Aroa Biosurgery (Formerly Mesynthes Limited) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aroa Biosurgery , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Aroa Biosurgery , Ltd.” (first 2017, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aroa Biosurgery , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aroa Biosurgery , Ltd. is 132 days. Since 2017: 132 days, versus 170 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aroa Biosurgery , Ltd.?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 4); FTM (Mesh, Surgical, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 10 Aroa Biosurgery , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGN, Aroa Biosurgery , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.