Aesculap Pneumatic Kerrison

FDA 510(k) K062413 · Aesculap, Inc.

Substantially Equivalent

510(k) numberK062413

Submission

Device name
Aesculap Pneumatic Kerrison
Applicant
Aesculap, Inc.
Center Valley, PA, US
Received
August 17, 2006
Decision date
November 21, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAD – Rongeur, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4845
Specialty
Neurology

Other 510(k)s with product code HAD

510(k)DeviceApplicantDecision
K022907Anspach Powered Kerrison System (PKS)HAD · Traditional The Anspach Effort, Inc.10/21/2002SE
K911637Stayfree, Unscented/Scented/Scented Deodor Men PadHAD · Traditional Personal Products Co.08/02/1991SE

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Questions and answers

When was Aesculap Pneumatic Kerrison cleared by the FDA?

Aesculap Pneumatic Kerrison (K062413) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 96 days after the submission was received.

What is the product code of K062413?

The FDA product code is HAD – Rongeur, Powered, a Class II (moderate risk) device regulated under 21 CFR 882.4845.