510(k) K252492
- Device
- Visualized Access and Delivery Catheter; PB Digital Controller
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- 510(k) number
- K252492
- Product code
- SHU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-24
- Date received
- 2025-08-08
- Regulation
- 876.1500
- Classification name
- Appendiceal Scope And Accessories, Flexible
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Sally He
- Address
- # 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial Development Zone Nanjing CN 210032 210032
FDA Registration Numbers
- 3013440400
- 3004837686