510(k) K903162

FLEXIBLE ENDOSCOPIC ELECTRODES by North American Sterilization & Packaging Co. — Product Code FAS

K903162 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "FLEXIBLE ENDOSCOPIC ELECTRODES". The FDA issued a decision of Substantially Equivalent on December 18, 1990. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
July 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type