510(k) K160625

Disposable Hot Biopsy Forceps by Micro-Tech (Nanjing) Co., Ltd. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2016
Date Received
March 4, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type