FDA 510(k)

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION

K-Number: K962393 · 1996-09-17

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1996-09-17

Product CodeGCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1996-09-17 under 510(k) number K962393. The device is classified under product code GCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION?

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION is a medical device that received FDA 510(k) clearance on 1996-09-17. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K962393.

When did KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION receive FDA 510(k) clearance?

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION received FDA 510(k) clearance on 1996-09-17, under 510(k) number K962393.

Who is the listed applicant for KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION?

The FDA product code for KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION is GCM.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

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Related Devices (Code: GCM)

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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.