FDA 510(k)

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

K-Number: K231854 · 2023-09-20

Decision Date2023-09-20

Product CodeOWN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2023-09-20 under approval number K231854. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Stryker. The 510(k) number is K231854.

When was 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM approved by the FDA?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM received FDA 510(k) clearance on 2023-09-20, under approval number K231854.

What company makes 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is manufactured by Stryker.

What is the FDA product code for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

The FDA product code for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is OWN.

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Related PubMed Literature

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Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

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.