Cleared Traditional

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

K031789 · Pentax Precision Instrument Corp. · Radiology

Aug 2003

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K031789 is an FDA 510(k) clearance for the EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE, a Endoscopic Ultrasound System, Gastroenterology-urology (Class II — Special Controls, product code ODG), submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on August 8, 2003, 59 days after receiving the submission on June 10, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K031789 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	ODG — Endoscopic Ultrasound System, Gastroenterology-urology
Device Class	Class II — 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).