Cleared Special

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (K103647) - FDA 510(k) Clearance

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

K103647 · Thd Spa · Gastroenterology & Urology device
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Mar 2011
Decision
78d
Days
Class 2
Risk

K103647 is an FDA 510(k) clearance for the THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND 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 March 1, 2011 after a review of 78 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

Submission Details

510(k) Number K103647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date March 01, 2011
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
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.

Regulatory Peers - FER Anoscope And Accessories

All 8
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K103647.
Gastro Concepts Air Assist
K242668 · Gastro Concepts, LLC · Dec 2024
WellCare Anoscope
K230439 · Well Care (Wuhan) Medical Technology Co., Ltd. · Dec 2023
Applied Medical Anoscope
K200021 · Applied Medical Resources · Jan 2021
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · Welch Allyn, Inc. · Feb 1981