Cleared Traditional

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (K212202) - FDA 510(k) Clearance

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

K212202 · OTU Medical, Inc. · Gastroenterology & Urology device
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Apr 2022
Decision
273d
Days
Class 2
Risk

K212202 is an FDA 510(k) clearance for the WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystos.... Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by OTU Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on April 13, 2022 after a review of 273 days - an extended review cycle.

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 OTU Medical, Inc. devices

Submission Details

510(k) Number K212202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2021
Decision Date April 13, 2022
Days to Decision 273 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
143d slower than avg
Panel avg: 130d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform 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 Consultant

Zi-medical, Inc.
Mingzi Hussey

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FAJ Cystoscope And Accessories, Flexible/rigid

All 49
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K212202.
Single-Use Flexible Cystoscope
K221580 · Hunan Vathin Medical Instrument Co., Ltd. · Nov 2022
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K222162 · Shanghai AnQing Medical Instrument Co., Ltd. · Nov 2022
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R
K222602 · Zhuhai Pusen Medical Technology Co., Ltd. · Sep 2022
KARL STORZ Flexible HD Cysto-Urethroscope System
K212476 · KARL STORZ Endoscopy-America, Inc. · Sep 2021
LUMINELLE DTx System
K210512 · Uvision360, Inc. · Jun 2021
Uro-G Cystoscope
K202921 · Uroviu Corporation · May 2021