Cleared Traditional

K120446 - FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE E...

K120446 is the FDA 510(k) clearance for FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE E... by Fujinon, Inc.. It is a Class 2 Radiology device (product code FDS) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K120446 · Fujinon, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
181d
Days
Class 2
Risk

K120446 is an FDA 510(k) clearance for the FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Fujinon, Inc. (Wayne, US). The FDA issued a Cleared decision on August 13, 2012 after a review of 181 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujinon, Inc. devices

Submission Details

510(k) Number K120446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2012
Decision Date August 13, 2012
Days to Decision 181 days
Submission Type Traditional
Review Panel Radiology (RA)
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
74d slower than avg
Panel avg: 107d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K120446.
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
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FOREIGN BODY HOOD
K130148 · United States Endoscopy Group, Inc. · Aug 2013
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
K123317 · Olympus Medical Systems Corporation · Dec 2012
FUJINON ULTRASONIC PROCESSOR
K111243 · Fujinon, Inc. · May 2011
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