Cleared Special

K160044 - Image1 SPIES System

K160044 is an FDA 510(k) clearance for Image1 SPIES System, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Special 510(k) pathway after a 24-day FDA review.

K160044 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
24d
Days
Class 2
Risk

K160044 is an FDA 510(k) clearance for the Image1 SPIES System. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on February 1, 2016 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 - K160044

510(k) Number K160044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2016
Decision Date February 01, 2016
Days to Decision 24 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 131d · This submission: 24d
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 Gastroenterology & Urology devices follow this clearance model.

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 K160044.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
K172817 · Olympus Medical Systems Corp. · Oct 2017
Processor VP-7000, Light Source BL-7000
K163675 · Fujifilm Medical System U.S.A., Inc. · Apr 2017
ENDOCAM Flex HD Camera System 5521
K161204 · Richard Wolf Medical Instruments Corporation · Jan 2017
HD-Camera HDC1000
K152109 · W.O.M. World of Medicine GmbH · Oct 2015
EPX-4440HD and EPX-4400HD with FICE
K150221 · Fujifilm Medical System U.S.A., Inc. · Oct 2015
IMAGE1 SPIES
K131953 · KARL STORZ Endoscopy-America, Inc. · Dec 2013
K160044 · Image1 SPIES System
Download PDF FDA Summary KARL STORZ Endoscopy-…