Cleared Traditional

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

K023401 · Pentax Precision Instrument Corp. · Radiology

Feb 2003

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K023401 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 February 11, 2003, 125 days after receiving the submission on October 9, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K023401 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2002
Decision Date	February 11, 2003
Days to Decision	125 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).