Cleared Traditional

K964037 - FLEXIBLE CYSTOSCOPE

K964037 is the FDA 510(k) clearance for FLEXIBLE CYSTOSCOPE by Applied Fiberoptics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K964037 · Applied Fiberoptics, Inc. · Gastroenterology & Urology device
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Feb 1997
Decision
135d
Days
Class 2
Risk

K964037 is an FDA 510(k) clearance for the FLEXIBLE CYSTOSCOPE. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Applied Fiberoptics, Inc. (Sturbridge, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 135 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 Applied Fiberoptics, Inc. devices

Submission Details

510(k) Number K964037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1996
Decision Date February 20, 1997
Days to Decision 135 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 130d · This submission: 135d
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 Peers - FAJ Cystoscope And Accessories, Flexible/rigid

All 63
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K964037.
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
K040215 · Vision-Sciences, Inc. · Apr 2004
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc. · May 2002
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
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K941779 · KARL STORZ Endoscopy-America, Inc. · Jun 1994