FDA 510(k)

KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP

K-Number: K950961 · 1995-05-25

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1995-05-25

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP 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 1995-05-25 under 510(k) number K950961. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP?

KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K950961.

When did KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP receive FDA 510(k) clearance?

KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP received FDA 510(k) clearance on 1995-05-25, under 510(k) number K950961.

Who is the listed applicant for KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP?

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 DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP?

The FDA product code for KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP is HIG.

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

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Related Devices (Code: HIG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.