Cleared Traditional

K201135 - Image1 S CCU

K201135 is the FDA 510(k) clearance for Image1 S CCU by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K201135 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
126d
Days
Class 2
Risk

K201135 is an FDA 510(k) clearance for the Image1 S CCU, Image1 S 4U Camera Head. 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 September 1, 2020 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K201135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2020
Decision Date September 01, 2020
Days to Decision 126 days
Submission Type Traditional
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
4d faster than avg
Panel avg: 130d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K201135.
Telepack +
K221174 · KARL STORZ Endoscopy-America, Inc. · May 2022
D Camera Controller
K211332 · Richard Wolf Medical Instruments Corporation · Oct 2021
Visera Elite II Video System Center
K202646 · Olympus Medical Systems Corp. · Oct 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
FUJIFILM EP-6000 Video Processor
K192286 · Fujifilm Corporation · May 2020