Cleared Special

K113050 - CLEARPATH LOWER GI

K113050 is an FDA 510(k) clearance for CLEARPATH LOWER GI, manufactured by Easyglide , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Special 510(k) pathway after a 216-day FDA review.

K113050 · Easyglide , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
216d
Days
Class 2
Risk

K113050 is an FDA 510(k) clearance for the CLEARPATH LOWER GI. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Easyglide , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on May 16, 2012 after a review of 216 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Easyglide , Ltd. devices

FDA 510(k) Submission Details - K113050

510(k) Number K113050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2011
Decision Date May 16, 2012
Days to Decision 216 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 130d · This submission: 216d
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 73
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K113050.
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K111028 · United States Endoscopy Group, Inc. · Nov 2011