FDA 510(k)

SICAT Endo

K-Number: K180262 · 2018-03-12

Decision Date2018-03-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SICAT Endo 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 2018-03-12 under 510(k) number K180262. 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 Endo?

SICAT Endo is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Sicat GmbH & Co. KG. The 510(k) number is K180262.

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

SICAT Endo received FDA 510(k) clearance on 2018-03-12, under 510(k) number K180262.

Who is the listed applicant for SICAT Endo?

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 Endo?

The FDA product code for SICAT Endo is LLZ.

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 V2.0 K153291SICAT OPTISLEEP

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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.