510(k) K150801

Stryker Maestro Air Motors by Stryker Corporation — Product Code HBB

K150801 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker Maestro Air Motors". The FDA issued a decision of Substantially Equivalent on May 22, 2015. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2015
Date Received
March 26, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type