Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SICAT Implant V2.0

K-Number: K192348 · 2019-12-04

ApplicantSicat GmbH & Co. KG
Decision Date2019-12-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SICAT Implant V2.0 is a medical device manufactured by Sicat GmbH & Co. KG. It received FDA 510(k) clearance on 2019-12-04 under approval number K192348. 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 V2.0?

SICAT Implant V2.0 is a medical device that received FDA 510(k) clearance on 2019-12-04. It is manufactured by Sicat GmbH & Co. KG. The 510(k) number is K192348.

When was SICAT Implant V2.0 approved by the FDA?

SICAT Implant V2.0 received FDA 510(k) clearance on 2019-12-04, under approval number K192348.

What company makes SICAT Implant V2.0?

SICAT Implant V2.0 is manufactured by Sicat GmbH & Co. KG.

What is the FDA product code for SICAT Implant V2.0?

The FDA product code for SICAT Implant V2.0 is LLZ.

Other Devices by Sicat GmbH & Co. KG

K153291SICAT OPTISLEEP K180262SICAT Endo

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑