Cleared Traditional

K254153 - Single-use Video Scope (FDA 510(k) Clearance)

Also includes:
PB Digital Controller

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254153 · Mirco-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
102d
Days
Class 2
Risk

K254153 is an FDA 510(k) clearance for the Single-use Video Scope. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Mirco-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on April 3, 2026 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mirco-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K254153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2025
Decision Date April 03, 2026
Days to Decision 102 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 130d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBN Choledochoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Bile Ducts. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FBN Choledochoscope And Accessories, Flexible/rigid

All 42
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K254153.
Disposable Distal Cap
K253139 · Mirco-Tech (Nanjing) Co., Ltd. · Mar 2026
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G
K251338 · Scivita Medical Technology Co., Ltd. · Jan 2026
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
K251170 · Tangent Endoscopy, LLC · Sep 2025
Flexible Video-Choledochoscope (CHV-110J-U)
K243535 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Mar 2025
Biliary Pancreaticobiliary Scope System
K241444 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Jan 2025
Dragonfly™ Pancreaticobiliary Scope
K233752 · CenterPoint Systems, LLC · May 2024