FDA 510(k)

Large Screws Range

K-Number: K160617 · 2016-06-03

Decision Date2016-06-03

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Large Screws Range is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2016-06-03 under 510(k) 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. The listed applicant is Newclip Technics. The 510(k) number is K160617.

When did Large Screws Range receive FDA 510(k) clearance?

Large Screws Range received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160617.

Who is the listed applicant for Large Screws Range?

The FDA 510(k) record lists Newclip Technics as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Newclip Technics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.