WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System— 510(k) K210579
Substantially EquivalentOTU Medical, Inc.
FDA 510(k) clearance K210579 for WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System, Substantially Equivalent on 2021-07-22. Applicant: OTU Medical, Inc..
Clearance details
- Applicant
- OTU Medical, Inc.
- Product code
- Code FGB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.