Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-12-12 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2022-09-09 | OAI | Official action indicated | Olympus Medical Systems Corporation | 1 |
| 2018-03-09 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2015-04-24 | OAI | Official action indicated | Olympus Medical Systems Corporation | 2 |
Similar devices
- 1788 STRYKER CORPORATION
- 4K UHD Camera System Scivita Medical Technology Co., Ltd.
- 4K UHD Camera System Scivita Medical Technology Co., Ltd.
- Aer-O-Scope Daily Tube Convenience Kit G.I. VIEW LTD
- Aer-O-Scope Water Bottle G.I. VIEW LTD
- Aer-O-Scope Workstation G.I. VIEW LTD
- Ambu® aScope™ Gastro Large Ambu A/S
- BioGuard US Endoscopy
- BioGuard US Endoscopy
- CRE Wireguided BOSTON SCIENTIFIC CORPORATION
- CRE Wireguided BOSTON SCIENTIFIC CORPORATION
- CRE Wireguided BOSTON SCIENTIFIC CORPORATION
Select up to two to place side-by-side with this device.