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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 the device name listed in this FDA 510(k) record. The listed applicant is Omec Medical, Inc.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) 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. The listed applicant is Omec Medical, Inc.. The 510(k) number is K201151.

When did O-Mec 690 Series Laparoscopes receive FDA 510(k) clearance?

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

Who is the listed applicant for O-Mec 690 Series Laparoscopes?

The FDA 510(k) record lists Omec Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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