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FDA 510(k)

Bladeless Trocar; Bladed Trocar; Hasson Trocar

K-Number: K241052 · 2024-10-04

ApplicantAdvamedix, GmbH
Decision Date2024-10-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bladeless Trocar; Bladed Trocar; Hasson Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Advamedix, GmbH. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241052. 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 Bladeless Trocar; Bladed Trocar; Hasson Trocar?

Bladeless Trocar; Bladed Trocar; Hasson Trocar is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Advamedix, GmbH. The 510(k) number is K241052.

When did Bladeless Trocar; Bladed Trocar; Hasson Trocar receive FDA 510(k) clearance?

Bladeless Trocar; Bladed Trocar; Hasson Trocar received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241052.

Who is the listed applicant for Bladeless Trocar; Bladed Trocar; Hasson Trocar?

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 Bladeless Trocar; Bladed Trocar; Hasson Trocar?

The FDA product code for Bladeless Trocar; Bladed Trocar; Hasson Trocar 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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