Cleared Traditional

K162882 - KARL STORZ ICG Imaging System

K162882 is the FDA 510(k) clearance for KARL STORZ ICG Imaging System by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 General & Plastic Surgery device (product code OWN) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K162882 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery device
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Jan 2017
Decision
104d
Days
Class 2
Risk

K162882 is an FDA 510(k) clearance for the KARL STORZ ICG Imaging System. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on January 26, 2017 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery 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 K162882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2016
Decision Date January 26, 2017
Days to Decision 104 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWN Confocal Optical Imaging

All 42
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K162882.
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
K183640 · Mauna Kea Technologies · Feb 2019
Stryker AIM Light Source and SafeLight cable
K173866 · Stryker · Jan 2018
KARL STORZ ICG Imaging System
K171238 · KARL STORZ Endoscopy-America, Inc. · May 2017
KARL STORZ Endoscopic ICG Imaging System
K152583 · KARL STORZ Endoscopy-America, Inc. · May 2016
Stryker Infrared Fluorescence (IRF) Imaging System
K142310 · Stryker Endoscopy · Dec 2014
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
K124031 · Intuitive Surgical, Inc. · Sep 2013