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FDA 510(k)

LIAC HWL

K-Number: K172961 · 2018-06-11

Decision Date2018-06-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIAC HWL is the device name listed in this FDA 510(k) record. The listed applicant is Sit Sordina Iort Technologies Spa. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K172961. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAC HWL?

LIAC HWL is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Sit Sordina Iort Technologies Spa. The 510(k) number is K172961.

When did LIAC HWL receive FDA 510(k) clearance?

LIAC HWL received FDA 510(k) clearance on 2018-06-11, under 510(k) number K172961.

Who is the listed applicant for LIAC HWL?

The FDA 510(k) record lists Sit Sordina Iort Technologies Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAC HWL?

The FDA product code for LIAC HWL is IYE.

Other records listing Sit Sordina Iort Technologies Spa 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.

Related Devices (Code: IYE)

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.

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.