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FDA 510(k)

CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045

K-Number: K080613 · 2008-11-06

ApplicantMinimally Invasive Devices, LLC
Decision Date2008-11-06
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 is the device name listed in this FDA 510(k) record. The listed applicant is Minimally Invasive Devices, LLC. It received FDA 510(k) clearance on 2008-11-06 under 510(k) number K080613. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045?

CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 is a medical device that received FDA 510(k) clearance on 2008-11-06. The listed applicant is Minimally Invasive Devices, LLC. The 510(k) number is K080613.

When did CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 receive FDA 510(k) clearance?

CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 received FDA 510(k) clearance on 2008-11-06, under 510(k) number K080613.

Who is the listed applicant for CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045?

The FDA 510(k) record lists Minimally Invasive Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045?

The FDA product code for CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 is OCT.

Related Clinical Trials

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Other records listing Minimally Invasive Devices, LLC 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.

K102452DEFOGGING AND CLEANING SOLUTION- FLO-X

Related Devices (Code: OCT)

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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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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