Cleared Traditional

K080132 - THD DISPOSABLE ANOSCOPE/PROCTOSCOPE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080132 · Thd Spa · Gastroenterology & Urology device
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Apr 2008
Decision
82d
Days
Class 2
Risk

K080132 is an FDA 510(k) clearance for the THD DISPOSABLE ANOSCOPE/PROCTOSCOPE. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Thd Spa (S. Lazzaro Di Savena, Bologna, IT). The FDA issued a Cleared decision on April 9, 2008 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thd Spa devices

Submission Details

510(k) Number K080132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2008
Decision Date April 09, 2008
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.