WiScope Digital Endoscope System— 510(k) K181977
Substantially EquivalentOTU Medical, Inc.
FDA 510(k) clearance K181977 for WiScope Digital Endoscope System, Substantially Equivalent on 2018-08-14. Applicant: OTU Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- OTU Medical, Inc.
- Product code
- Code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code FGB
view all- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K253505 — Zamenix P
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
More clearances from OTU Medical, Inc.
view all- K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
- K220399 — WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
- K212202 — WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
- K210579 — WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
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.