OTU Medical, Inc.
OTU Medical, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Jan 8, 2025 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Sep 29, 2023.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 8, 2025 | Union City, CA | Devices | No Action Indicated (NAI) | 3013992977 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope®… | Sep 29, 2023 |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image… | Jun 16, 2022 |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image… | Apr 13, 2022 |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope… | Jul 22, 2021 |
| K181977 | WiScope Digital Endoscope System | Aug 14, 2018 |