510(k) K141794

ENDO-MARYLAND DISSECTOR by Ovesco Endoscopy AG — Product Code KGE

K141794 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "ENDO-MARYLAND DISSECTOR". The FDA issued a decision of Substantially Equivalent on November 19, 2014. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Ovesco Endoscopy AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2014
Date Received
July 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type