510(k) K123553

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM by Zimmer, Inc. — Product Code KCY

K123553 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM". The FDA issued a decision of Substantially Equivalent on August 9, 2013. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2013
Date Received
November 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type