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FDA 510(k)

COOK WIRE GUIDES

K-Number: K082536 · 2008-10-27

ApplicantCook Urological, Inc.
Decision Date2008-10-27
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK WIRE GUIDES is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2008-10-27 under 510(k) number K082536. 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 COOK WIRE GUIDES?

COOK WIRE GUIDES is a medical device that received FDA 510(k) clearance on 2008-10-27. The listed applicant is Cook Urological, Inc.. The 510(k) number is K082536.

When did COOK WIRE GUIDES receive FDA 510(k) clearance?

COOK WIRE GUIDES received FDA 510(k) clearance on 2008-10-27, under 510(k) number K082536.

Who is the listed applicant for COOK WIRE GUIDES?

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

What is the FDA product code for COOK WIRE GUIDES?

The FDA product code for COOK WIRE GUIDES is OCY.

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Other records listing Cook Urological, Inc. as applicant

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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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