Cleared Traditional

K031789 - EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031789 · Pentax Precision Instrument Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
59d
Days
Class 2
Risk

K031789 is an FDA 510(k) clearance for the EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on August 8, 2003 after a review of 59 days - a notably fast clearance 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: 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K031789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date August 08, 2003
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. 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 Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 41
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K031789.
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K251859 · Olympus Medical Systems Corporation · Oct 2025
InstaFAN
K251542 · Onepass Medical , Ltd. · Jul 2025
Ultrasonic Gastrovideoscope
K231813 · Sonoscape Medical Corp. · Mar 2024
EndoSound Vision System
K232518 · Endosound, Inc. · Dec 2023
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K223616 · Boston Scientific Corporation · Dec 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · Fujifilm Corporation · Aug 2022