Visualized Access and Delivery Catheter; PB Digital Controller
FDA 510(k) clearance K252492 · decided 2026-04-24
Clearance details
- K-number
- K252492
- Device name
- Visualized Access and Delivery Catheter; PB Digital Controller
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-08
- Decision date
- 2026-04-24
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- SHU
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Nanjing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.