HAD — Rongeur, Powered Class II

FDA Device Classification

FDA product code HAD covers "Rongeur, Powered", a Class II medical device regulated under 21 CFR 882.4845. Submissions are reviewed by the Neurology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HAD
Device Class
Class II
Regulation Number
882.4845
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K062413aesculapAESCULAP PNEUMATIC KERRISONNovember 21, 2006
K022907anspach effortANSPACH POWERED KERRISON SYSTEM (PKS)October 21, 2002
K911637personal productsSTAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PADAugust 2, 1991