OTU Medical Inc
Union City, CA, US
OTU Medical Inc appears in FDA device records in Union City, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for OTU Medical Inc between 2018 and 2023. The busiest year on record is 2022, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | FAJ | Substantially Equivalent | |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | EOQ | Substantially Equivalent | |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | FAJ | Substantially Equivalent | |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | FGB | Substantially Equivalent | |
| K181977 | WiScope Digital Endoscope System | FGB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013992977 | 3013992977 | OTU Medical Inc | 2847A Whipple Rd., Union City, CA 94587 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain