510(k) K252492
K252492 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Visualized Access and Delivery Catheter; PB Digital Controller". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code SHU (Appendiceal Scope And Accessories, Flexible), a Class II device regulated under 21 CFR 876.1500. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2026
- Date Received
- August 8, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appendiceal Scope And Accessories, Flexible
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall.