510(k) K141935

STRYKER S2 DRILL by Stryker Corporation — Product Code ERL

K141935 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "STRYKER S2 DRILL". The FDA issued a decision of Substantially Equivalent on September 26, 2014. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2014
Date Received
July 17, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type