FDA 510(k)

SICAT OPTISLEEP

K-Number: K153291 · 2016-03-31

Decision Date2016-03-31

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SICAT OPTISLEEP 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 2016-03-31 under 510(k) number K153291. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SICAT OPTISLEEP?

SICAT OPTISLEEP is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Sicat GmbH & Co. KG. The 510(k) number is K153291.

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

SICAT OPTISLEEP received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153291.

Who is the listed applicant for SICAT OPTISLEEP?

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 OPTISLEEP?

The FDA product code for SICAT OPTISLEEP is LRK.

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 K180262SICAT Endo

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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.