510(k) K873654

MONOPOLAR CAUTERY CONICAL TIP #TM-1702 by Arthropedics, Inc. — Product Code JOS

K873654 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "MONOPOLAR CAUTERY CONICAL TIP #TM-1702". The FDA issued a decision of Substantially Equivalent on December 15, 1987. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Arthropedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1987
Date Received
September 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type