OXINIUM DH Fermoral Heads
K-Number: K161233 · 2016-12-14
ApplicantSmith & Nephew, Inc.
Decision Date2016-12-14
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OXINIUM DH Fermoral Heads is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-12-14 under approval number K161233. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OXINIUM DH Fermoral Heads?
OXINIUM DH Fermoral Heads is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K161233.
When was OXINIUM DH Fermoral Heads approved by the FDA?
OXINIUM DH Fermoral Heads received FDA 510(k) clearance on 2016-12-14, under approval number K161233.
What company makes OXINIUM DH Fermoral Heads?
OXINIUM DH Fermoral Heads is manufactured by Smith & Nephew, Inc..
What is the FDA product code for OXINIUM DH Fermoral Heads?
The FDA product code for OXINIUM DH Fermoral Heads is MBL.
Other Devices by Smith & Nephew, Inc.
Related Devices (Code: MBL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.