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FDA 510(k)

MINI FLEX COIL

K-Number: K961628 · 1996-09-05

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-09-05
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINI FLEX COIL is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K961628. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI FLEX COIL?

MINI FLEX COIL is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K961628.

When did MINI FLEX COIL receive FDA 510(k) clearance?

MINI FLEX COIL received FDA 510(k) clearance on 1996-09-05, under 510(k) number K961628.

Who is the listed applicant for MINI FLEX COIL?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI FLEX COIL?

The FDA product code for MINI FLEX COIL is MOS.

Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: MOS)

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.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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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