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FDA 510(k)

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003

K-Number: K093718 · 2010-02-22

ApplicantZutron Medical, LLC
Decision Date2010-02-22
Product CodeFCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 is the device name listed in this FDA 510(k) record. The listed applicant is Zutron Medical, LLC. It received FDA 510(k) clearance on 2010-02-22 under 510(k) number K093718. The device is classified under product code FCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003?

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 is a medical device that received FDA 510(k) clearance on 2010-02-22. The listed applicant is Zutron Medical, LLC. The 510(k) number is K093718.

When did ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 receive FDA 510(k) clearance?

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 received FDA 510(k) clearance on 2010-02-22, under 510(k) number K093718.

Who is the listed applicant for ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003?

The FDA 510(k) record lists Zutron Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003?

The FDA product code for ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 is FCY.

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Related Devices (Code: FCY)

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.

K904376ANEROID BLOOD PRESSURE GAUGEBiomedical Dynamics, Inc.K900016TRANS/R - FP(3)CIVCO Medical Instruments Co., 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.

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