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FDA 510(k)

Single Use Irrigation bipolar cable

K-Number: K211170 · 2021-10-19

ApplicantModern Medical Equipment Manufacturing, Ltd.
Decision Date2021-10-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single Use Irrigation bipolar cable is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K211170. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Irrigation bipolar cable?

Single Use Irrigation bipolar cable is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K211170.

When did Single Use Irrigation bipolar cable receive FDA 510(k) clearance?

Single Use Irrigation bipolar cable received FDA 510(k) clearance on 2021-10-19, under 510(k) number K211170.

Who is the listed applicant for Single Use Irrigation bipolar cable?

The FDA 510(k) record lists Modern Medical Equipment Manufacturing, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Irrigation bipolar cable?

The FDA product code for Single Use Irrigation bipolar cable is GEI.

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Related Devices (Code: GEI)

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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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