Flexible Video-Choledochoscope System
FDA 510(k) clearance K222261 · decided 2023-04-20
Clearance details
- K-number
- K222261
- Device name
- Flexible Video-Choledochoscope System
- Applicant
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-28
- Decision date
- 2023-04-20
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.