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FDA 510(k)

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

K-Number: K233333 · 2023-11-21

ApplicantKarl Storz SE & CO. KG
Decision Date2023-11-21
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K233333. 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 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit?

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K233333.

When did KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit receive FDA 510(k) clearance?

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233333.

Who is the listed applicant for KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit?

The FDA product code for KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is OWN.

Related Clinical Trials

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Other records listing Karl Storz SE & 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.

K261706Endomat Select (UP220)K252800KARL STORZ Endoscopic Accessories for UrologyK254228KARL STORZ Trocars with Valve SealsK260003KARL STORZ Mediastinoscopes and InstrumentsK254242KARL STORZ ICG Imaging System with RUBINA® LensK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)

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Related Devices (Code: OWN)

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.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

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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