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FDA 510(k)

ELMED Laparoscopic Instruments and Accessories

K-Number: K181173 · 2019-03-22

ApplicantElmed Incorporated
Decision Date2019-03-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELMED Laparoscopic Instruments and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Elmed Incorporated. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181173. 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 ELMED Laparoscopic Instruments and Accessories?

ELMED Laparoscopic Instruments and Accessories is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Elmed Incorporated. The 510(k) number is K181173.

When did ELMED Laparoscopic Instruments and Accessories receive FDA 510(k) clearance?

ELMED Laparoscopic Instruments and Accessories received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181173.

Who is the listed applicant for ELMED Laparoscopic Instruments and Accessories?

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

What is the FDA product code for ELMED Laparoscopic Instruments and Accessories?

The FDA product code for ELMED Laparoscopic Instruments and Accessories is GCJ.

Related Clinical Trials

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.

NCT06119568Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RPCOMPLETED

Related Devices (Code: GCJ)

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.

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