Visualized Access and Delivery Catheter; PB Digital Controller
FDA 510(k) K252492 · Micro-Tech (Nanjing) Co., Ltd.
Submission
- Device name
- Visualized Access and Delivery Catheter; PB Digital Controller
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- August 8, 2025
- Decision date
- April 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SHU – Appendiceal Scope And Accessories, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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.
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Questions and answers
When was Visualized Access and Delivery Catheter; PB Digital Controller cleared by the FDA?
Visualized Access and Delivery Catheter; PB Digital Controller (K252492) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 259 days after the submission was received.
What is the product code of K252492?
The FDA product code is SHU – Appendiceal Scope And Accessories, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.1500.