Cleared Traditional

K970595 - CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

K970595 is an FDA 510(k) clearance for CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP, manufactured by Circon Video. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K970595 · Circon Video · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
248d
Days
Class 2
Risk

K970595 is an FDA 510(k) clearance for the CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Circon Video (Santa Barbara, US). The FDA issued a Cleared decision on October 24, 1997 after a review of 248 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Circon Video devices

FDA 510(k) Submission Details - K970595

510(k) Number K970595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date October 24, 1997
Days to Decision 248 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 130d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FEN Device, Cystometric, Hydraulic

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