510(k) K861220

LUNDERQUIST - RING PTC DRAINAGE CATHETER by Meadox Surgimed, Inc. — Product Code FGE

K861220 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "LUNDERQUIST - RING PTC DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on May 19, 1986. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1986
Date Received
April 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type