510(k) K882048

MEDITRON ENDOLAV MODEL EL-100 by Xylog Corp. — Product Code KNS

K882048 is an FDA 510(k) premarket notification submitted by Xylog Corp. for the device "MEDITRON ENDOLAV MODEL EL-100". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Xylog Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
May 16, 1988
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