Cleared Special

K202646 - Visera Elite II Video System Center

K202646 is an FDA 510(k) clearance for Visera Elite II Video System Center, manufactured by Olympus Medical Systems Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code FET cleared through the Special 510(k) pathway after a 48-day FDA review.

K202646 · Olympus Medical Systems Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
48d
Days
Class 2
Risk

K202646 is an FDA 510(k) clearance for the Visera Elite II Video System Center. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 29, 2020 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 876.1500 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K202646

510(k) Number K202646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2020
Decision Date October 29, 2020
Days to Decision 48 days
Submission Type Special
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
113d faster than avg
Panel avg: 161d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 Surgical Technologies of America
Anne-Marie Keefe

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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 100
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K202646.
Logic Hd camera head green, System green
K212808 · Richard Wolf Medical Instruments Corporation · Jun 2022
Telepack +
K221174 · KARL STORZ Endoscopy-America, Inc. · May 2022
D Camera Controller
K211332 · Richard Wolf Medical Instruments Corporation · Oct 2021
Image1 S CCU, Image1 S 4U Camera Head
K201135 · KARL STORZ Endoscopy-America, Inc. · Sep 2020
Visera Elite II Video System Center
K201200 · Olympus Medical Systems Corp. · Jul 2020
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
K200617 · Richard Wolf Medical Instruments Corporation · Jun 2020
K202646 · Visera Elite II Video System Center
Download PDF FDA Summary Olympus Medical Syste…