Cleared Traditional

ANSPACH POWERED KERRISON SYSTEM (PKS)

K022907 · The Anspach Effort, Inc. · Neurology

Oct 2002

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K022907 is an FDA 510(k) clearance for the ANSPACH POWERED KERRISON SYSTEM (PKS), a Rongeur, Powered (Class II — Special Controls, product code HAD), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on October 21, 2002, 48 days after receiving the submission on September 3, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4845.

Submission Details

510(k) Number	K022907 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2002
Decision Date	October 21, 2002
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF