510(k) K850111

AIRES TUOHY NEEDLES 17GA. X 4 1/2 by Aries Medical, Inc. — Product Code BSP

K850111 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "AIRES TUOHY NEEDLES 17GA. X 4 1/2". The FDA issued a decision of Substantially Equivalent on January 24, 1985. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1985
Date Received
January 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type