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FDA 510(k)

Suction Irrigation Tubing Set

K-Number: K242927 · 2024-11-22

ApplicantAdvamedix, GmbH
Decision Date2024-11-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Suction Irrigation Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Advamedix, GmbH. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K242927. 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 Suction Irrigation Tubing Set?

Suction Irrigation Tubing Set is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Advamedix, GmbH. The 510(k) number is K242927.

When did Suction Irrigation Tubing Set receive FDA 510(k) clearance?

Suction Irrigation Tubing Set received FDA 510(k) clearance on 2024-11-22, under 510(k) number K242927.

Who is the listed applicant for Suction Irrigation Tubing Set?

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

What is the FDA product code for Suction Irrigation Tubing Set?

The FDA product code for Suction Irrigation Tubing Set is GCJ.

Other records listing Advamedix, GmbH as applicant

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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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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