FDA 510(k)

ePTFE-Coated Auricular Implant

K-Number: K172389 · 2018-07-18

Decision Date2018-07-18

Product CodeFZD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ePTFE-Coated Auricular Implant is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K172389. The device is classified under product code FZD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePTFE-Coated Auricular Implant?

ePTFE-Coated Auricular Implant is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K172389.

When did ePTFE-Coated Auricular Implant receive FDA 510(k) clearance?

ePTFE-Coated Auricular Implant received FDA 510(k) clearance on 2018-07-18, under 510(k) number K172389.

Who is the listed applicant for ePTFE-Coated Auricular Implant?

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

What is the FDA product code for ePTFE-Coated Auricular Implant?

The FDA product code for ePTFE-Coated Auricular Implant is FZD.

Other records listing Implantech Associates, Inc. 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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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.