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FDA 510(k)

CONDUIT LLIF Straight Inserters

K-Number: K223671 · 2023-01-05

ApplicantEnztec Limited
Decision Date2023-01-05
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONDUIT LLIF Straight 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 2023-01-05 under 510(k) number K223671. 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 LLIF Straight Inserters?

CONDUIT LLIF Straight Inserters is a medical device that received FDA 510(k) clearance on 2023-01-05. The listed applicant is Enztec Limited. The 510(k) number is K223671.

When did CONDUIT LLIF Straight Inserters receive FDA 510(k) clearance?

CONDUIT LLIF Straight Inserters received FDA 510(k) clearance on 2023-01-05, under 510(k) number K223671.

Who is the listed applicant for CONDUIT LLIF Straight 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 LLIF Straight Inserters?

The FDA product code for CONDUIT LLIF Straight 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)

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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