510(k) K141557 ยท HRX Arthroscope
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
| Applicant | Gallini Medical Devices, Srl, South Euclid OH, US |
| Decision | Substantially Equivalent, Dec 8, 2014 |
| Received | Jun 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2021 | ADRIA SRL Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715 Terminated |
HRX | None listed |
| May 17, 2021 | ADRIA SRL Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745 Terminated |
HRX | None listed |
| May 17, 2021 | ADRIA SRL Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.