Cleared Special

K091490 - FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES

K091490 is an FDA 510(k) clearance for FAMILY OF THD DISPOSABLE ANOSCOPES/PROC..., manufactured by Thd Spa. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Special 510(k) pathway after a 22-day FDA review.

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.

View all Thd Spa devices

FDA 510(k) Submission Details - K091490

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

FER Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FER Anoscope And Accessories

All 23
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K091490.
GELPOINT PATH
K110792 · Applied Medical Resources Corp. · May 2011
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
K103647 · Thd Spa · Mar 2011
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
HEMORPEX SYSTEM
K090432 · Angiologica B. M. Srl · May 2009
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
K080132 · Thd Spa · Apr 2008
SELF-LIGHT DISPOSABLE ANOSCOPE
K070913 · Sapimed S.P.A. · Aug 2007