AEON
Model AEPH260 · LEXINGTON MEDICAL, INC. · DI 00850060791031
GAG — Stapler, Surgical · Class II · 21 CFR 878.4740
GDW — Staple, Implantable · Class II · 21 CFR 878.4750
UDILibrary device dossier · generated 2026-09-12 · 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 | 9.76 |
| 2019-02 | 0 | 9.35 |
| 2019-03 | 0 | 10.19 |
| 2019-04 | 0 | 10.33 |
| 2019-05 | 0 | 8.74 |
| 2019-06 | 0 | 10.56 |
| 2019-07 | 0 | 10.62 |
| 2019-08 | 0 | 8.97 |
| 2019-09 | 0 | 8.99 |
| 2019-10 | 0 | 9.49 |
| 2019-11 | 0 | 9.54 |
| 2019-12 | 0 | 9.63 |
| 2020-01 | 0 | 9.44 |
| 2020-02 | 0 | 8.37 |
| 2020-03 | 0 | 9.03 |
| 2020-04 | 0 | 7.57 |
| 2020-05 | 0 | 6.89 |
| 2020-06 | 0 | 8.55 |
| 2020-07 | 0 | 9.61 |
| 2020-08 | 0 | 9.42 |
| 2020-09 | 0 | 9.59 |
| 2020-10 | 0 | 9.8 |
| 2020-11 | 0 | 9.33 |
| 2020-12 | 0 | 9.98 |
| 2021-01 | 0 | 8.95 |
| 2021-02 | 0 | 8.45 |
| 2021-03 | 0 | 8.85 |
| 2021-04 | 0 | 9.7 |
| 2021-05 | 0 | 8.94 |
| 2021-06 | 0 | 8.93 |
| 2021-07 | 0 | 9.01 |
| 2021-08 | 0 | 11.22 |
| 2021-09 | 0 | 10.02 |
| 2021-10 | 0 | 9.74 |
| 2021-11 | 0 | 8.3 |
| 2021-12 | 0 | 9.96 |
| 2022-01 | 0 | 8.72 |
| 2022-02 | 0 | 8.49 |
| 2022-03 | 0 | 9.46 |
| 2022-04 | 0 | 8.93 |
| 2022-05 | 0 | 9.11 |
| 2022-06 | 0 | 10.16 |
| 2022-07 | 0 | 8.99 |
| 2022-08 | 0 | 9.77 |
| 2022-09 | 0 | 9.03 |
| 2022-10 | 0 | 10.11 |
| 2022-11 | 0 | 10.03 |
| 2022-12 | 0 | 10.19 |
| 2023-01 | 0 | 9.35 |
| 2023-02 | 0 | 9.81 |
| 2023-03 | 0 | 12.04 |
| 2023-04 | 0 | 9.45 |
| 2023-05 | 0 | 9.46 |
| 2023-06 | 0 | 10.49 |
| 2023-07 | 0 | 10.44 |
| 2023-08 | 0 | 8.48 |
| 2023-09 | 0 | 8.17 |
| 2023-10 | 0 | 8.43 |
| 2023-11 | 0 | 8.14 |
| 2023-12 | 0 | 8.99 |
| 2024-01 | 0 | 9.93 |
| 2024-02 | 0 | 9.64 |
| 2024-03 | 0 | 7.77 |
| 2024-04 | 0 | 8.79 |
| 2024-05 | 0 | 7.62 |
| 2024-06 | 0 | 8.61 |
| 2024-07 | 0 | 8.56 |
| 2024-08 | 0 | 7.24 |
| 2024-09 | 0 | 10 |
| 2024-10 | 0 | 8.27 |
| 2024-11 | 0 | 9.53 |
| 2024-12 | 0 | 7.13 |
| 2025-01 | 0 | 8.49 |
| 2025-02 | 0 | 7.23 |
| 2025-03 | 0 | 7.38 |
| 2025-04 | 0 | 7.02 |
| 2025-05 | 0 | 9.08 |
| 2025-06 | 0 | 8.48 |
| 2025-07 | 0 | 11.61 |
| 2025-08 | 0 | 9.37 |
| 2025-09 | 0 | 9.84 |
| 2025-10 | 0 | 9.08 |
| 2025-11 | 0 | 9.47 |
| 2025-12 | 0 | 11.24 |
| 2026-01 | 0 | 9.51 |
| 2026-02 | 0 | 9.96 |
| 2026-03 | 0 | 10.57 |
| 2026-04 | 0 | 9.5 |
| 2026-05 | 0 | 8.73 |
| 2026-06 | 0 | 11.32 |
Regulatory clearances
- K234039 SESE 2024-05-07 (k number procode)
Predicate lineage
K234039 — cites (transitively): K163454 (d1), K222210 (d1), K112056 (d2), K131663 (d2), K140560 (d2), K160521 (d2), K201882 (d2), K070887 (d3), K051002 (d3), K121600 (d3), K182380 (d3), K173443 (d4), K061095 (d5), K141367 (d5), K171589 (d5), K120179 (d6), K131511 (d6) — cited as predicate by K251482
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LEXINGTON MEDICAL, INC.
Nothing in the loaded window.