Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
FDA 510(k) clearance K233778 · decided 2024-07-16
Clearance details
- K-number
- K233778
- Device name
- Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
- Applicant
- Zhuhai Pusen Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-27
- Decision date
- 2024-07-16
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- FGB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Zhuhai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.