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FDA 510(k)

Amsel Occluder Device

K-Number: K172479 · 2017-09-14

ApplicantAmsel Medical
Decision Date2017-09-14
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Amsel Occluder Device is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K172479. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amsel Occluder Device?

Amsel Occluder Device is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Amsel Medical. The 510(k) number is K172479.

When did Amsel Occluder Device receive FDA 510(k) clearance?

Amsel Occluder Device received FDA 510(k) clearance on 2017-09-14, under 510(k) number K172479.

Who is the listed applicant for Amsel Occluder Device?

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

What is the FDA product code for Amsel Occluder Device?

The FDA product code for Amsel Occluder Device is FZP.

Other records listing Amsel Medical 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.

K180650Amsel Endo Occluder

Related Devices (Code: FZP)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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