Cleared Traditional

K032092 - OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

K032092 is an FDA 510(k) clearance for OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHRO..., manufactured by Olympus Optical Co., Ltd.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K032092 · Olympus Optical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
9d
Days
Class 1
Risk

K032092 is an FDA 510(k) clearance for the OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Olympus Optical Co., Ltd. (Nishitama-Gun Tokyo, JP). The FDA issued a Cleared decision on July 16, 2003 after a review of 9 days - a notably fast clearance 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: 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 Olympus Optical Co., Ltd. devices

FDA 510(k) Submission Details - K032092

510(k) Number K032092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date July 16, 2003
Days to Decision 9 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 131d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Intertek Testing Services
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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 K032092.
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
K973611 · Spectrascience, Inc. · Dec 1997
AUXILIARY INSTRUMENTS FOR URS
K971315 · Richard Wolf Medical Instruments Corp. · Sep 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

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.