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FDA 510(k)

KARL STORZ New Generation Trocars

K-Number: K180977 · 2018-07-18

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2018-07-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ New Generation Trocars is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2018-07-18 under approval number K180977. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ New Generation Trocars?

KARL STORZ New Generation Trocars is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K180977.

When was KARL STORZ New Generation Trocars approved by the FDA?

KARL STORZ New Generation Trocars received FDA 510(k) clearance on 2018-07-18, under approval number K180977.

What company makes KARL STORZ New Generation Trocars?

KARL STORZ New Generation Trocars is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for KARL STORZ New Generation Trocars?

The FDA product code for KARL STORZ New Generation Trocars is GCJ.

Related Clinical Trials

NCT06281730 Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy ENROLLING_BY_INVITATION

Other Devices by KARL STORZ Endoscopy-America, Inc.

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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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