Cleared Traditional

K992715 - NEURO URODYNAMIC SUITE, MODEL 9032E0101 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992715 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device
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Feb 2000
Decision
200d
Days
Class 2
Risk

K992715 is an FDA 510(k) clearance for the NEURO URODYNAMIC SUITE, MODEL 9032E0101. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on February 28, 2000 after a review of 200 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 Medtronic Functional Diagnostics A/S devices

Submission Details

510(k) Number K992715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1999
Decision Date February 28, 2000
Days to Decision 200 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
70d slower than avg
Panel avg: 130d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.