Large Screws Range
K-Number: K160617 · 2016-06-03
ApplicantNewclip Technics
Decision Date2016-06-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Large Screws Range is a medical device manufactured by Newclip Technics. It received FDA 510(k) clearance on 2016-06-03 under approval number K160617. 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 Large Screws Range?
Large Screws Range is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Newclip Technics. The 510(k) number is K160617.
When was Large Screws Range approved by the FDA?
Large Screws Range received FDA 510(k) clearance on 2016-06-03, under approval number K160617.
What company makes Large Screws Range?
Large Screws Range is manufactured by Newclip Technics.
What is the FDA product code for Large Screws Range?
The FDA product code for Large Screws Range 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.