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FDA 510(k)

URESIL GUIDEWIRE

K-Number: K972582 · 1997-11-21

ApplicantUresil Corp.
Decision Date1997-11-21
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URESIL GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K972582. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL GUIDEWIRE?

URESIL GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Uresil Corp.. The 510(k) number is K972582.

When did URESIL GUIDEWIRE receive FDA 510(k) clearance?

URESIL GUIDEWIRE received FDA 510(k) clearance on 1997-11-21, under 510(k) number K972582.

Who is the listed applicant for URESIL GUIDEWIRE?

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

What is the FDA product code for URESIL GUIDEWIRE?

The FDA product code for URESIL GUIDEWIRE is FGE.

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.

Other records listing Uresil Corp. 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.

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Related Devices (Code: FGE)

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.

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.

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