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FDA 510(k)

ACIF

K-Number: K173148 · 2017-12-01

ApplicantColigne AG
Decision Date2017-12-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACIF is the device name listed in this FDA 510(k) record. The listed applicant is Coligne AG. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K173148. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIF?

ACIF is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Coligne AG. The 510(k) number is K173148.

When did ACIF receive FDA 510(k) clearance?

ACIF received FDA 510(k) clearance on 2017-12-01, under 510(k) number K173148.

Who is the listed applicant for ACIF?

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

What is the FDA product code for ACIF?

The FDA product code for ACIF is ODP.

Other records listing Coligne AG 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: ODP)

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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