510(k) K946109

CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS by Cabot Medical Corp. — Product Code KNS

K946109 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS". The FDA issued a decision of Substantially Equivalent on November 21, 1995. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1995
Date Received
December 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type