Cleared Traditional

K012929 - FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE

K012929 is an FDA 510(k) clearance for FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, manufactured by Circon Video. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K012929 · Circon Video · Gastroenterology & Urology device
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Nov 2001
Decision
80d
Days
Class 2
Risk

K012929 is an FDA 510(k) clearance for the FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Circon Video (Santa Barbara, US). The FDA issued a Cleared decision on November 19, 2001 after a review of 80 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.

View all Circon Video devices

FDA 510(k) Submission Details - K012929

510(k) Number K012929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2001
Decision Date November 19, 2001
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
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 63
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K012929.
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K043022 · Stryker Endoscopy · Mar 2005
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