BePOD® EZ Weil Screws
K-Number: K163710 · 2017-09-08
ApplicantFournitures Hospitalieres Industrie
Decision Date2017-09-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BePOD® EZ Weil Screws is a medical device manufactured by Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2017-09-08 under approval number K163710. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BePOD® EZ Weil Screws?
BePOD® EZ Weil Screws is a medical device that received FDA 510(k) clearance on 2017-09-08. It is manufactured by Fournitures Hospitalieres Industrie. The 510(k) number is K163710.
When was BePOD® EZ Weil Screws approved by the FDA?
BePOD® EZ Weil Screws received FDA 510(k) clearance on 2017-09-08, under approval number K163710.
What company makes BePOD® EZ Weil Screws?
BePOD® EZ Weil Screws is manufactured by Fournitures Hospitalieres Industrie.
What is the FDA product code for BePOD® EZ Weil Screws?
The FDA product code for BePOD® EZ Weil Screws is HWC. This falls under the Cardiovascular category.
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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.