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FDA 510(k)

O-Mec 690 Series Laparoscopes

K-Number: K201151 · 2020-06-22

ApplicantOmec Medical, Inc.
Decision Date2020-06-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

O-Mec 690 Series Laparoscopes is a medical device manufactured by Omec Medical, Inc.. It received FDA 510(k) clearance on 2020-06-22 under approval number K201151. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O-Mec 690 Series Laparoscopes?

O-Mec 690 Series Laparoscopes is a medical device that received FDA 510(k) clearance on 2020-06-22. It is manufactured by Omec Medical, Inc.. The 510(k) number is K201151.

When was O-Mec 690 Series Laparoscopes approved by the FDA?

O-Mec 690 Series Laparoscopes received FDA 510(k) clearance on 2020-06-22, under approval number K201151.

What company makes O-Mec 690 Series Laparoscopes?

O-Mec 690 Series Laparoscopes is manufactured by Omec Medical, Inc..

What is the FDA product code for O-Mec 690 Series Laparoscopes?

The FDA product code for O-Mec 690 Series Laparoscopes is GCJ.

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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.

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