Cleared Traditional

ENDOEYE HD II

K111788 · Olympus America, Inc. · Obstetrics & Gynecology
Jan 2012
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K111788 is an FDA 510(k) clearance for the ENDOEYE HD II, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Olympus America, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 13, 2012, 203 days after receiving the submission on June 24, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K111788 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2011
Decision Date January 13, 2012
Days to Decision 203 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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