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FDA 510(k)

HEMEDEX FIXATION DEVICE

K-Number: K032127 · 2003-12-30

ApplicantHemedex Incorporated
Decision Date2003-12-30
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMEDEX FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Hemedex Incorporated. It received FDA 510(k) clearance on 2003-12-30 under 510(k) number K032127. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMEDEX FIXATION DEVICE?

HEMEDEX FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2003-12-30. The listed applicant is Hemedex Incorporated. The 510(k) number is K032127.

When did HEMEDEX FIXATION DEVICE receive FDA 510(k) clearance?

HEMEDEX FIXATION DEVICE received FDA 510(k) clearance on 2003-12-30, under 510(k) number K032127.

Who is the listed applicant for HEMEDEX FIXATION DEVICE?

The FDA 510(k) record lists Hemedex Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMEDEX FIXATION DEVICE?

The FDA product code for HEMEDEX FIXATION DEVICE is KNY.

Related Clinical Trials

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.

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Other records listing Hemedex Incorporated 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.

K032337HEMEDEX CRANIAL BOLT MODELS, 3601, 3602K013376QFLOW 500 PERFUSION MONITORING SYSTEM

Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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