Cleared Traditional

K993689 - AED CYSTOSCOPE

K993689 is an FDA 510(k) clearance for AED CYSTOSCOPE, manufactured by National Advanced Endoscopy Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K993689 · National Advanced Endoscopy Devices, Inc. · Gastroenterology & Urology device
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Dec 1999
Decision
44d
Days
Class 2
Risk

K993689 is an FDA 510(k) clearance for the AED CYSTOSCOPE. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by National Advanced Endoscopy Devices, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 15, 1999 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K993689

510(k) Number K993689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date December 15, 1999
Days to Decision 44 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 131d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAJ Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K993689.
CYSTOSCOPES
K003807 · Global Endoscopy, Inc. · Feb 2001
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
K993041 · The Olympus Optical Co. · Mar 2000
CORTEK CYSTOSCOPE
K000197 · Cortek Endoscopy, Inc. · Mar 2000
BAHO AUTOCLAVABLE CYSTOSCOPE
K992983 · Innovative Endoscopy Components, LLC · Oct 1999
MEDIFIX INC.
K992483 · Medifix, Inc. · Aug 1999
MEDIVISION CYSTOSCOPE
K982620 · Medivision Scope Service Center, Inc. · Sep 1998