Cleared Traditional

K031789 - EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

K031789 is an FDA 510(k) clearance for EG-3830UT, manufactured by Pentax Precision Instrument Corp.. The device is a Class 2 Radiology device with product code ODG cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K031789 · Pentax Precision Instrument Corp. · Radiology device
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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

FDA 510(k) Submission Details - K031789

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
Combination Product No
PCCP Authorized No
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.

ODG Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K031789.
EG-3870UTK
K090197 · Pentax Medical Company · May 2009
EG-3670URK
K061068 · Pentax Medical Company · May 2006
OLYMPUS BF TYPE UC160-OL8
K042140 · Olympus Corporation · Aug 2004
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
K031347 · Olympus Optical Co., Ltd. · May 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K023401 · Pentax Precision Instrument Corp. · Feb 2003
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K021276 · Pentax Precision Instrument Corp. · Sep 2002