Smith & Nephew VISIONAIRE Adaptive Guides
K-Number: K170282 · 2017-05-22
ApplicantSmith & Nephew, Inc.
Decision Date2017-05-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Smith & Nephew VISIONAIRE Adaptive Guides is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-05-22 under approval number K170282. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Smith & Nephew VISIONAIRE Adaptive Guides?
Smith & Nephew VISIONAIRE Adaptive Guides is a medical device that received FDA 510(k) clearance on 2017-05-22. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K170282.
When was Smith & Nephew VISIONAIRE Adaptive Guides approved by the FDA?
Smith & Nephew VISIONAIRE Adaptive Guides received FDA 510(k) clearance on 2017-05-22, under approval number K170282.
What company makes Smith & Nephew VISIONAIRE Adaptive Guides?
Smith & Nephew VISIONAIRE Adaptive Guides is manufactured by Smith & Nephew, Inc..
What is the FDA product code for Smith & Nephew VISIONAIRE Adaptive Guides?
The FDA product code for Smith & Nephew VISIONAIRE Adaptive Guides is JWH.
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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.