Device recall
Z-0510-2020: GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with…
FDA device recall · Class II · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-0510-2020 |
|---|---|
| Recall event | 83909 |
| Product | GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or… |
| Product code | FER |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2021 |
| 510(k) numbers | K171701 |
| FEI number | 2027111 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database