Cleared Traditional

CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)

K971584 · Clarus Medical Systems, Inc. · Gastroenterology & Urology

May 1997

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K971584 is an FDA 510(k) clearance for the CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES), a Endoscope Holder (Class II — Special Controls, product code OCV), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 23, 1997, 23 days after receiving the submission on April 30, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K971584 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 1997
Decision Date	May 23, 1997
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCV — Endoscope Holder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Hold Endoscope In A Desired Position During Procedures.