Cleared Traditional

K971315 - AUXILIARY INSTRUMENTS FOR URS

K971315 is an FDA 510(k) clearance for AUXILIARY INSTRUMENTS FOR URS, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K971315 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971315

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 131d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

FCL Device Classification - Class 1, General Controls

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.

Regulatory Peers - FCL Forceps, Biopsy, Non-electric

All 19
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K971315.
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
K032092 · Olympus Optical Co., Ltd. · Jul 2003
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
K973611 · Spectrascience, Inc. · Dec 1997
INJECTO FLUSH
K964120 · Robert J. Jynch, Jr. · Dec 1996
SPECTRA SCIENCE BIOPSY FORCEPS
K963517 · Spectrascience, Inc. · Dec 1996
OLYMPUS FB SERIES BIOPSY FORCEPS
K955065 · Olympus America, Inc. · Jan 1996
FORCEPS, BIOPSY, NON-ELECTRIC
K952863 · Annex Medical, Inc. · Jul 1995