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FDA 510(k)

NvisionVLE Imaging System, NvisionVLE Optical Probe

K-Number: K182261 · 2018-10-16

ApplicantNinepoint Medical, Inc.
Decision Date2018-10-16
Product CodeNQQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

NvisionVLE Imaging System, NvisionVLE Optical Probe is the device name listed in this FDA 510(k) record. The listed applicant is Ninepoint Medical, Inc.. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K182261. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NvisionVLE Imaging System, NvisionVLE Optical Probe?

NvisionVLE Imaging System, NvisionVLE Optical Probe is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Ninepoint Medical, Inc.. The 510(k) number is K182261.

When did NvisionVLE Imaging System, NvisionVLE Optical Probe receive FDA 510(k) clearance?

NvisionVLE Imaging System, NvisionVLE Optical Probe received FDA 510(k) clearance on 2018-10-16, under 510(k) number K182261.

Who is the listed applicant for NvisionVLE Imaging System, NvisionVLE Optical Probe?

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

What is the FDA product code for NvisionVLE Imaging System, NvisionVLE Optical Probe?

The FDA product code for NvisionVLE Imaging System, NvisionVLE Optical Probe is NQQ.

Other records listing Ninepoint Medical, 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.

K191117NvisionVLE Low-profile Optical ProbeK182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemK153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

Related Devices (Code: NQQ)

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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