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FDA 510(k)

VERTEX Nitinol Staple System

K-Number: K182943 · 2019-04-04

ApplicantNvision Biomedical Technologies, LLC
Decision Date2019-04-04
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTEX Nitinol Staple System is a medical device manufactured by Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2019-04-04 under approval number K182943. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEX Nitinol Staple System?

VERTEX Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Nvision Biomedical Technologies, LLC. The 510(k) number is K182943.

When was VERTEX Nitinol Staple System approved by the FDA?

VERTEX Nitinol Staple System received FDA 510(k) clearance on 2019-04-04, under approval number K182943.

What company makes VERTEX Nitinol Staple System?

VERTEX Nitinol Staple System is manufactured by Nvision Biomedical Technologies, LLC.

What is the FDA product code for VERTEX Nitinol Staple System?

The FDA product code for VERTEX Nitinol Staple System is JDR.

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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.

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