510(k) K943935

GIP/MEDI-GLOBE POLYPECTOMY SNARES by Medi-Globe Corp. — Product Code FDI

K943935 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MEDI-GLOBE POLYPECTOMY SNARES". The FDA issued a decision of Substantially Equivalent on May 26, 1995. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Medi-Globe Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1995
Date Received
August 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type