510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252492Substantially Equivalent

Visualized Access and Delivery Catheter; PB Digital Controller

Micro-Tech (Nanjing) Co., Ltd., Nanjing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252492 is the FDA 510(k) clearance record for Visualized Access and Delivery Catheter; PB Digital Controller, a class II device, cleared for Micro-Tech (Nanjing) Co., Ltd. on under FDA product code SHU (Appendiceal Scope And Accessories, Flexible). FDA's definition for product code SHU reads: "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...". FDA records list 41 510(k) clearances for Micro-Tech (Nanjing) Co., Ltd., from to . As of , FDA records show no recalls naming K252492.

Clearance record

Decision date
Received
(259 days to decision)
Product code
SHU Appendiceal Scope And Accessories, Flexible
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Micro-Tech (Nanjing) Co., Ltd. # 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial, Nanjing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SHU

Trailing 12 months
1 clearance under product code SHU in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260