Cleared Traditional

K032177 - GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM

K032177 is an FDA 510(k) clearance for GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, manufactured by Olympus Opto-Electronics Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K032177 · Olympus Opto-Electronics Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
78d
Days
Class 2
Risk

K032177 is an FDA 510(k) clearance for the GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14M.... Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Olympus Opto-Electronics Co., Ltd. (Melville, US). The FDA issued a Cleared decision on October 2, 2003 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Opto-Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K032177

510(k) Number K032177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2003
Decision Date October 02, 2003
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDS Device Classification - Class 2, Special Controls

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDS Gastroscope And Accessories, Flexible/rigid

All 65
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K032177.
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K063847 · Fujinon, Inc. · Mar 2007
KARL STORZ VIDEO GASTROSCOPES
K060907 · KARL STORZ Endoscopy-America, Inc. · Nov 2006
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
K042043 · Fujinon, Inc. · Nov 2004
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · Pentax Precision Instrument Corp. · Feb 2002
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
K984358 · Olympus America, Inc. · Sep 1999
VG 200 VIDEO GASTROSCOPE
K971734 · Welch Allyn, Inc. · Jul 1997