Cleared Traditional

K042043 - FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5

K042043 is an FDA 510(k) clearance for FUJINON INC. G5 GASTROSCOPES, manufactured by Fujinon, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDS cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K042043 · Fujinon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
118d
Days
Class 2
Risk

K042043 is an FDA 510(k) clearance for the FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Fujinon, Inc. (Huntington, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 118 days - within the typical 510(k) review window.

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: 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 Fujinon, Inc. devices

FDA 510(k) Submission Details - K042043

510(k) Number K042043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2004
Decision Date November 24, 2004
Days to Decision 118 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
13d faster than avg
Panel avg: 131d · This submission: 118d
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 75
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K042043.
FUJINON MODEL EG-530N TRANS NASAL INSERTION
K063316 · Fujinon, Inc. · Mar 2007
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K063847 · Fujinon, Inc. · Mar 2007
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K060907 · KARL STORZ Endoscopy-America, Inc. · Nov 2006
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
K021886 · Olympus Optical Co., Ltd. · Jun 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · Pentax Precision Instrument Corp. · Feb 2002
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
K011151 · The Olympus Optical Co. · May 2001