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FDA 510(k)

SICAT IMPLANT

K-Number: K090119 · 2009-02-05

ApplicantSicat GmbH & Co. KG
Decision Date2009-02-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SICAT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sicat GmbH & Co. KG. It received FDA 510(k) clearance on 2009-02-05 under 510(k) number K090119. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SICAT IMPLANT?

SICAT IMPLANT is a medical device that received FDA 510(k) clearance on 2009-02-05. The listed applicant is Sicat GmbH & Co. KG. The 510(k) number is K090119.

When did SICAT IMPLANT receive FDA 510(k) clearance?

SICAT IMPLANT received FDA 510(k) clearance on 2009-02-05, under 510(k) number K090119.

Who is the listed applicant for SICAT IMPLANT?

The FDA 510(k) record lists Sicat GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SICAT IMPLANT?

The FDA product code for SICAT IMPLANT is LLZ.

Related Clinical Trials

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Other records listing Sicat GmbH & Co. KG 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.

K192348SICAT Implant V2.0K180262SICAT EndoK153291SICAT OPTISLEEPK103723SICAT IMPLANT V1.2K093090GALILEOS IMPLANT, VERSION 1.7K061472GALILEOS IMPLANT, V 1.0

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Related Devices (Code: LLZ)

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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