510(k) K030765

HOBBS MISTIFIER SPRAY CATHETER by Hobbs Medical, Inc. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2003
Date Received
March 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.