Cleared Special

K171238 - KARL STORZ ICG Imaging System

K171238 is an FDA 510(k) clearance for KARL STORZ ICG Imaging System, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OWN cleared through the Special 510(k) pathway after a 28-day FDA review.

K171238 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
28d
Days
Class 2
Risk

K171238 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 May 25, 2017 after a review of 28 days - a notably fast clearance cycle.

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. 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 - K171238

510(k) Number K171238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2017
Decision Date May 25, 2017
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

OWN Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K171238.
Stryker AIM Light Source and SafeLight cable
K173866 · Stryker · Jan 2018
Cellvizio 100 Series System with Confocal Miniprobes
K172844 · Mauna Kea Technologies · Dec 2017
Cellvizio 100 Series Systems with Confocal Miniprobes
K171345 · Mauna Kea Technologies · Aug 2017
KARL STORZ ICG Imaging System
K162882 · KARL STORZ Endoscopy-America, Inc. · Jan 2017
SPY Phi Open Field Handheld Fluorescence Imaging System
K162885 · Novadaq Technologies, Inc. · Jan 2017
KARL STORZ Endoscopic ICG Imaging System
K152583 · KARL STORZ Endoscopy-America, Inc. · May 2016
K171238 · KARL STORZ ICG Imaging System
Download PDF FDA Summary KARL STORZ Endoscopy-…