Cleared Special

K091490 - FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K091490 · Thd Spa · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
22d
Days
Class 2
Risk

K091490 is an FDA 510(k) clearance for the FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Thd Spa (Imoa, IT). The FDA issued a Cleared decision on June 11, 2009 after a review of 22 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.

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Submission Details

510(k) Number K091490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2009
Decision Date June 11, 2009
Days to Decision 22 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
108d faster than avg
Panel avg: 130d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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.