HBO — Clip, Scalp Class II

FDA Device Classification

FDA product code HBO covers "Clip, Scalp", a Class II medical device regulated under 21 CFR 882.4150. Submissions are reviewed by the Neurology panel. At least 10 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HBO
Device Class
Class II
Regulation Number
882.4150
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050044medtronic neurosurgeryMEDTRONIC CLIP GUN KITFebruary 7, 2005
K033660rudolf storzSTORZ RANEY SCALP CLIP, MODEL 1-20-004-05January 7, 2004
K012219aesculapSCALPFIX CLIP SYSTEMJuly 31, 2001
K944311acra cutACRA-CUTNovember 18, 1994
K905433codman and shurtleffCODMAN DISPOSABLE SCALP CLIP APPLIERFebruary 21, 1991
K896723omni medical designsCLIP GUN WITH RANEY TYPE SCALP CLIPSMarch 23, 1990
K894778codman and shurtleffCODMAN RF-12 DISPOSABLE SCALP CLIP APPLIERDecember 6, 1989
K890443aesculap instrumentsCASPAR SCALP CLIP, APPLIERJune 15, 1989
K883963new england surgical instrumentRANEY AND LEROY-RANEY SCALP CLIPOctober 7, 1988
K881265zimmerRANEY CLIPSMay 31, 1988