Cleared Traditional

FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

K061651 · Apple Medical Corp. · Obstetrics & Gynecology

Oct 2006

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K061651 is an FDA 510(k) clearance for the FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Apple Medical Corp. (Marlboro, US). The FDA issued a Cleared decision on October 20, 2006, 129 days after receiving the submission on June 13, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number	K061651 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2006
Decision Date	October 20, 2006
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF