Cleared Special

K110214 - DIRECTVISION CATHETER, UNCOATED

K110214 is an FDA 510(k) clearance for DIRECTVISION CATHETER, manufactured by Percuvision. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Special 510(k) pathway after a 122-day FDA review.

K110214 · Percuvision · Gastroenterology & Urology device
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May 2011
Decision
122d
Days
Class 2
Risk

K110214 is an FDA 510(k) clearance for the DIRECTVISION CATHETER, UNCOATED. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Percuvision (Ashland, US). The FDA issued a Cleared decision on May 27, 2011 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Percuvision devices

FDA 510(k) Submission Details - K110214

510(k) Number K110214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2011
Decision Date May 27, 2011
Days to Decision 122 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
9d faster than avg
Panel avg: 131d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZL Catheter, Retention Type, Balloon

All 112
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