Cleared Traditional

Ureterorenoscope System (K180367) - FDA 510(k) Clearance

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

K180367 · Shanghai AnQing Medical Instrument Co., Ltd. · Gastroenterology & Urology device
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Jul 2018
Decision
141d
Days
Class 2
Risk

K180367 is an FDA 510(k) clearance for the Ureterorenoscope System. 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 July 3, 2018 after a review of 141 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 K180367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date July 03, 2018
Days to Decision 141 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
11d slower than avg
Panel avg: 130d · This submission: 141d
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 79
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K180367.
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
K183188 · Richard Wolf Medical Instruments Corporation · May 2019
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
K181451 · Olympus Medical Systems Corp. · Jan 2019
WiScope Digital Endoscope System
K181977 · OTU Medical, Inc. · Aug 2018
OLYMPUS URF-V2/V2R
K172246 · Olympus Medical Systems Corp. · Mar 2018
OLYMPUS URF-P6/P6R
K172298 · Olympus Medical Systems Corp. · Mar 2018
LithoVue System
K153049 · Boston Scientific Corporation · Nov 2015