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FDA 510(k)

ENDO-GLIDE GUIDEWIRE

K-Number: K023603 · 2003-02-19

ApplicantEndo-Therapeutics, Inc.
Decision Date2003-02-19
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO-GLIDE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Endo-Therapeutics, Inc.. It received FDA 510(k) clearance on 2003-02-19 under 510(k) number K023603. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-GLIDE GUIDEWIRE?

ENDO-GLIDE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2003-02-19. The listed applicant is Endo-Therapeutics, Inc.. The 510(k) number is K023603.

When did ENDO-GLIDE GUIDEWIRE receive FDA 510(k) clearance?

ENDO-GLIDE GUIDEWIRE received FDA 510(k) clearance on 2003-02-19, under 510(k) number K023603.

Who is the listed applicant for ENDO-GLIDE GUIDEWIRE?

The FDA 510(k) record lists Endo-Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO-GLIDE GUIDEWIRE?

The FDA product code for ENDO-GLIDE GUIDEWIRE is OCY.

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Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, 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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