Self-Light Disposable Anoscope

FDA 510(k) K070913 · Sapimed S.P.A.

Substantially Equivalent

510(k) numberK070913

Submission

Device name
Self-Light Disposable Anoscope
Applicant
Sapimed S.P.A.
Crofton, MD, US
Received
April 2, 2007
Decision date
August 10, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FER – Anoscope And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To examine and perform procedures within the anus and rectum.

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K133687THD N-Ano AnoscopeFER · Special Thd Spa12/11/2013SE
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K110792Gelpoint PathFER · Traditional Applied Medical Resources Corp.05/23/2011SE

More from Applied Medical Resources Corp.

510(k)DeviceDecision
K070881Lem Hemorrhoidal Ligator, Models A.5650, A.5660FHN · Traditional 09/26/2007SE
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Questions and answers

When was Self-Light Disposable Anoscope cleared by the FDA?

Self-Light Disposable Anoscope (K070913) received a 510(k) decision of Substantially Equivalent on August 10, 2007, 130 days after the submission was received.

What is the product code of K070913?

The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.