Cleared Traditional

K151011 - VISERA 4K UHD SYSTEM

K151011 is the FDA 510(k) clearance for VISERA 4K UHD SYSTEM by Olympus Medical Systems Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K151011 · Olympus Medical Systems Corp. · Obstetrics & Gynecology device
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Oct 2015
Decision
169d
Days
Class 2
Risk

K151011 is an FDA 510(k) clearance for the VISERA 4K UHD SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 1, 2015 after a review of 169 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K151011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date October 01, 2015
Days to Decision 169 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 160d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Olympus Corporation of the Americas
Daphney Germain-Kolawole

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 118
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