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FDA 510(k)

TriMed Nitinol Staple System

K-Number: K190166 · 2019-07-01

ApplicantTriMed, Inc.
Decision Date2019-07-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Nitinol Staple System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2019-07-01 under approval number K190166. 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 TriMed Nitinol Staple System?

TriMed Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2019-07-01. It is manufactured by TriMed, Inc.. The 510(k) number is K190166.

When was TriMed Nitinol Staple System approved by the FDA?

TriMed Nitinol Staple System received FDA 510(k) clearance on 2019-07-01, under approval number K190166.

What company makes TriMed Nitinol Staple System?

TriMed Nitinol Staple System is manufactured by TriMed, Inc..

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

The FDA product code for TriMed 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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