510(k) K834401

URETERAL DOUBLE PIGTAIL STENT by Hobbs Medical, Inc. — Product Code FAD

K834401 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "URETERAL DOUBLE PIGTAIL STENT". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type