510(k) K252492

Visualized Access and Delivery Catheter; PB Digital Controller by Micro-Tech (Nanjing) Co., Ltd. — Product Code SHU

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.

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K220424 — Through the Scope Tracheal Stent System (July 8, 2022)
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