OviTex® 2S
Model F10258-0610G · AROA BIOSURGERY LIMITED · DI 09421904065369
FTM — Mesh, Surgical · Class II · 21 CFR 878.3300
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 2.27 |
| 2019-03 | 0 | 1.53 |
| 2019-04 | 0 | 2.1 |
| 2019-05 | 0 | 1.63 |
| 2019-06 | 0 | 2.06 |
| 2019-07 | 0 | 1.83 |
| 2019-08 | 0 | 1.4 |
| 2019-09 | 0 | 1.83 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 1.5 |
| 2019-12 | 0 | 2.4 |
| 2020-01 | 0 | 2.07 |
| 2020-02 | 0 | 3 |
| 2020-03 | 0 | 2.53 |
| 2020-04 | 0 | 2.33 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1.71 |
| 2020-07 | 0 | 1.88 |
| 2020-08 | 0 | 1.25 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 1.17 |
| 2020-11 | 0 | 1.6 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 1.81 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1.33 |
| 2021-04 | 0 | 1.38 |
| 2021-05 | 0 | 1.92 |
| 2021-06 | 0 | 2.67 |
| 2021-07 | 0 | 1.33 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.29 |
| 2021-10 | 0 | 1.31 |
| 2021-11 | 0 | 1.14 |
| 2021-12 | 0 | 2.33 |
| 2022-01 | 0 | 2.43 |
| 2022-02 | 0 | 1.86 |
| 2022-03 | 0 | 1.5 |
| 2022-04 | 0 | 1.4 |
| 2022-05 | 0 | 1.82 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 1.6 |
| 2022-08 | 0 | 2.64 |
| 2022-09 | 0 | 2.73 |
| 2022-10 | 0 | 2.43 |
| 2022-11 | 0 | 1.78 |
| 2022-12 | 0 | 1.5 |
| 2023-01 | 0 | 2.93 |
| 2023-02 | 0 | 2.33 |
| 2023-03 | 0 | 2.2 |
| 2023-04 | 0 | 8.25 |
| 2023-05 | 0 | 2.94 |
| 2023-06 | 0 | 2.18 |
| 2023-07 | 0 | 2.77 |
| 2023-08 | 0 | 2.08 |
| 2023-09 | 0 | 2.29 |
| 2023-10 | 0 | 2.2 |
| 2023-11 | 0 | 1.67 |
| 2023-12 | 0 | 1.73 |
| 2024-01 | 0 | 1.64 |
| 2024-02 | 0 | 1.2 |
| 2024-03 | 0 | 1.55 |
| 2024-04 | 0 | 1.78 |
| 2024-05 | 0 | 1.69 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.8 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 1.43 |
| 2024-12 | 0 | 1.86 |
| 2025-01 | 0 | 2.75 |
| 2025-02 | 0 | 2.13 |
| 2025-03 | 0 | 1.5 |
| 2025-04 | 0 | 1.29 |
| 2025-05 | 0 | 2.13 |
| 2025-06 | 0 | 1.33 |
| 2025-07 | 0 | 4.5 |
| 2025-08 | 0 | 1.8 |
| 2025-09 | 0 | 1.5 |
| 2025-10 | 0 | 1.71 |
| 2025-11 | 0 | 2.17 |
| 2025-12 | 0 | 2.33 |
| 2026-01 | 0 | 2.13 |
| 2026-02 | 0 | 1.33 |
| 2026-03 | 0 | 3.67 |
| 2026-04 | 0 | 2.8 |
| 2026-05 | 0 | 1.33 |
| 2026-06 | 0 | 2.75 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K153633 — cites (transitively): K130547 (d1), K153663 (d1), K062697 (d2), K070560 (d2), K092096 (d2), K101546 (d2), K102592 (d2), K830889 (d2), K980431 (d2), K061205 (d2), K061435 (d2), K071425 (d3), K993948 (d3), K984374 (d3) — cited as predicate by K153632, K162461, K231305, K250598
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — AROA BIOSURGERY LIMITED
- VAI 2017-03-09 Aroa Biosurgery Ltd · 0 citations
- VAI 2017-03-09 Aroa Biosurgery Ltd · 0 citations