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FDA 510(k)

TAXI ENDOSCOPIC GUIDEWIRE

K-Number: K081708 · 2008-08-26

ApplicantLake Region Mfg., Inc.
Decision Date2008-08-26
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TAXI ENDOSCOPIC GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 2008-08-26 under 510(k) number K081708. 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 TAXI ENDOSCOPIC GUIDEWIRE?

TAXI ENDOSCOPIC GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2008-08-26. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K081708.

When did TAXI ENDOSCOPIC GUIDEWIRE receive FDA 510(k) clearance?

TAXI ENDOSCOPIC GUIDEWIRE received FDA 510(k) clearance on 2008-08-26, under 510(k) number K081708.

Who is the listed applicant for TAXI ENDOSCOPIC GUIDEWIRE?

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

What is the FDA product code for TAXI ENDOSCOPIC GUIDEWIRE?

The FDA product code for TAXI ENDOSCOPIC GUIDEWIRE is OCY.

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Other records listing Lake Region Mfg., 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.

K092965TRAILRUNNER GUIDEWIRESK082922FREEWAY AND RAILRUNNER GUIDEWIRESK080144MANDREL GUIDEWIRES OR M-WIRESK073655PEGASUS STEERABLE (PTCA) GUIDEWIREK060454TITAN GUIDEWIREK052347TITAN STEERABLE (PTCA) GUIDEWIRE

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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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