Device recall
Z-0991-2021: SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage…
FDA device recall · Class II · Aomori Olympus Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0991-2021 |
|---|---|
| Recall event | 87074 |
| Product | SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. |
| Product code | FGX |
| Recalling firm | Aomori Olympus Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2024 |
| 510(k) numbers | K172734 |
| FEI number | 3003995201 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 Products in the same recall event
- 10–99 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