Cleared Traditional

K243857 - Flexible Ureterorenoscope (US27F-12-EU

Also marketed or referenced as:
US27F-12-US)

K243857 is the FDA 510(k) clearance for Flexible Ureterorenoscope (US27F-12-EU by Shanghai AnQing Medical Instrument Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K243857 · Shanghai AnQing Medical Instrument Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
116d
Days
Class 2
Risk

K243857 is an FDA 510(k) clearance for the Flexible Ureterorenoscope (US27F-12-EU. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 11, 2025 after a review of 116 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 Shanghai AnQing Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K243857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date April 11, 2025
Days to Decision 116 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
14d faster than avg
Panel avg: 130d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. 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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 85
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K243857.
Single-use Flexible Ureteroscope
K250785 · Hunan Vathin Medical Instrument Co., Ltd. · May 2025
F88 URE-SD/RD Flexible Ureteroscope
K243894 · Sg Endoscopy Pte, Ltd. · May 2025
LumiRex Ureteroscope
K243532 · Contra Healthcare Solutions, LLC · Apr 2025
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P
K243708 · Scivita Medical Technology Co., Ltd. · Mar 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
K243155 · Dongguan Zsr Biomedical Technology Company Limited · Feb 2025
Digital Video Processor
K243117 · Hunan Vathin Medical Instrument Co., Ltd. · Jan 2025