510(k) K073551

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

K073551 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 May 21, 2008. 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
May 21, 2008
Date Received
December 18, 2007
Clearance Type
Abbreviated
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