Cleared Special

K021074 - VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE...

K021074 is the FDA 510(k) clearance for VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE... by Olympus America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K021074 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
30d
Days
Class 2
Risk

K021074 is an FDA 510(k) clearance for the VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on May 2, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K021074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date May 02, 2002
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - FAJ Cystoscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K021074.
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
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K040215 · Vision-Sciences, Inc. · Apr 2004
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · Richard Wolf Medical Instruments Corp. · May 1998
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K945527 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
K943176 · KARL STORZ Endoscopy-America, Inc. · Dec 1994