510(k) K102544

SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY by Smith & Nephew Inc., Endoscopy Div. — Product Code KCT

K102544 is an FDA 510(k) premarket notification submitted by Smith & Nephew Inc., Endoscopy Div. for the device "SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY". The FDA issued a decision of Substantially Equivalent on January 5, 2011. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Smith & Nephew Inc., Endoscopy Div. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2011
Date Received
September 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type