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FDA 510(k)

CONDUIT™ ATP Inserters

K-Number: K232014 · 2023-09-01

ApplicantEnztec Limited
Decision Date2023-09-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONDUIT™ ATP Inserters is the device name listed in this FDA 510(k) record. The listed applicant is Enztec Limited. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232014. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONDUIT™ ATP Inserters?

CONDUIT™ ATP Inserters is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Enztec Limited. The 510(k) number is K232014.

When did CONDUIT™ ATP Inserters receive FDA 510(k) clearance?

CONDUIT™ ATP Inserters received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232014.

Who is the listed applicant for CONDUIT™ ATP Inserters?

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

What is the FDA product code for CONDUIT™ ATP Inserters?

The FDA product code for CONDUIT™ ATP Inserters is MAX.

Other records listing Enztec Limited 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: MAX)

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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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