510(k) K161514

Precision Thin Reciprocating Blade, 0.010in. by Stryker Corporation — Product Code EQJ

K161514 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Precision Thin Reciprocating Blade, 0.010in.". The FDA issued a decision of Substantially Equivalent on January 17, 2017. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2017
Date Received
June 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type