510(k) K092551

SMITH & NEPHEW INSTRUMENT TRAYS by Smith & Nephew Inc., Endoscopy Div. — Product Code KCT

K092551 is an FDA 510(k) premarket notification submitted by Smith & Nephew Inc., Endoscopy Div. for the device "SMITH & NEPHEW INSTRUMENT TRAYS". The FDA issued a decision of Substantially Equivalent on September 14, 2010. 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
September 14, 2010
Date Received
August 20, 2009
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