510(k) K180018

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2018
Date Received
January 2, 2018
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