Cleared Traditional

K221690 - OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5)

K221690 is the FDA 510(k) clearance for OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5) by Olympus Medical Systems Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K221690 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Dec 2022
Decision
202d
Days
Class 2
Risk

K221690 is an FDA 510(k) clearance for the OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMP.... Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on December 29, 2022 after a review of 202 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K221690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2022
Decision Date December 29, 2022
Days to Decision 202 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
72d slower than avg
Panel avg: 130d · This submission: 202d
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

Olympus Corporation of the Americas
Teffany Hutto

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 59
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K221690.
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
K231702 · OTU Medical, Inc. · Sep 2023
Endo SmartCap
K223040 · Medivators, Inc. · Mar 2023
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
K221683 · Olympus Medical Systems Corporation · Jan 2023
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