Data / Medical devices / United States / OTU Medical Inc
OTU Medical Inc: FDA-registered device maker in Union City, CA, United States, 5 510(k) clearances
OTU Medical Inc is registered with the FDA (registration 3013992977) in Union City, CA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013992977
- Address
- 2847A Whipple Rd., Union City, CA, United States, 94587
- Owner or operator
- OTU MEDICAL INC. (10058788)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 28, 2018
- Registered through
- 2026
- Brand names listed
- Aptra Digital Cystoscope System, Aptra Digital Endoscope System, Aptra Image System, Aptra Single-Use Digital Flexible Cystoscope, Aptra Single-Use Digital Flexible Ureteroscope, WiScope Digital Bronchoscope System, WiScope® Digital Cystoscope System, WiScope® Digital Endoscope System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2023 | K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | FAJ | Substantially Equivalent | OTU Medical, Inc. | accessdata.fda.gov |
| June 16, 2022 | K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | EOQ | Substantially Equivalent | OTU Medical, Inc. | accessdata.fda.gov |
| April 13, 2022 | K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | FAJ | Substantially Equivalent | OTU Medical, Inc. | accessdata.fda.gov |
| July 22, 2021 | K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | FGB | Substantially Equivalent | OTU Medical, Inc. | accessdata.fda.gov |
| August 14, 2018 | K181977 | WiScope Digital Endoscope System | FGB | Substantially Equivalent | OTU Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Choledochoscope And Accessories, Flexible/Rigid
Updated September 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.