Cleared Special

K081004 - PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL

K081004 is an FDA 510(k) clearance for PROTECTISCOPE CS COLONOSCOPE, manufactured by Stryker GI. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Special 510(k) pathway after a 24-day FDA review.

K081004 · Stryker GI · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
24d
Days
Class 2
Risk

K081004 is an FDA 510(k) clearance for the PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Stryker GI (Flower Mound, US). The FDA issued a Cleared decision on May 2, 2008 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 - K081004

510(k) Number K081004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2008
Decision Date May 02, 2008
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.

FDF Device Classification - Class 2, Special Controls

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDF Colonoscope And Accessories, Flexible/rigid

All 114
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K081004.
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
K091783 · Avantis Medical Systems, Inc. · Jul 2009
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K090116 · Fujinon, Inc. · Apr 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K083180 · Avantis Medical Systems, Inc. · Feb 2009
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL
K080317 · Syntheon, LLC · Apr 2008
NEOGUIDE ENDOSCOPY SYSTEM
K070622 · Neoguide Systems, Inc. · Aug 2007
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K070330 · Avantis Medical Systems, Inc. · Apr 2007
K081004 · PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
Download PDF FDA Summary Stryker GI