Cleared Traditional

K971315 - AUXILIARY INSTRUMENTS FOR URS (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K971315 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Sep 1997
Decision
159d
Days
Class 1
Risk

K971315 is an FDA 510(k) clearance for the AUXILIARY INSTRUMENTS FOR URS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on September 15, 1997 after a review of 159 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K971315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1997
Decision Date September 15, 1997
Days to Decision 159 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
29d slower than avg
Panel avg: 130d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.