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FDA 510(k)

SICAT IMPLANT V1.2

K-Number: K103723 · 2011-05-20

ApplicantSicat GmbH & Co. KG
Decision Date2011-05-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SICAT IMPLANT V1.2 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 2011-05-20 under 510(k) number K103723. 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 V1.2?

SICAT IMPLANT V1.2 is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Sicat GmbH & Co. KG. The 510(k) number is K103723.

When did SICAT IMPLANT V1.2 receive FDA 510(k) clearance?

SICAT IMPLANT V1.2 received FDA 510(k) clearance on 2011-05-20, under 510(k) number K103723.

Who is the listed applicant for SICAT IMPLANT V1.2?

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 V1.2?

The FDA product code for SICAT IMPLANT V1.2 is LLZ.

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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 OPTISLEEPK093090GALILEOS IMPLANT, VERSION 1.7K090119SICAT IMPLANTK061472GALILEOS IMPLANT, V 1.0

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Related Devices (Code: LLZ)

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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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