510(k) K993306

NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) by Paladin Medical, Inc. — Product Code HAM

K993306 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)". The FDA issued a decision of Substantially Equivalent on November 3, 1999. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1999
Date Received
October 4, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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