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FDA 510(k)

BLADEVIEW

K-Number: K101042 · 2010-10-29

ApplicantAccogent, LLC
Decision Date2010-10-29
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BLADEVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Accogent, LLC. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K101042. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADEVIEW?

BLADEVIEW is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Accogent, LLC. The 510(k) number is K101042.

When did BLADEVIEW receive FDA 510(k) clearance?

BLADEVIEW received FDA 510(k) clearance on 2010-10-29, under 510(k) number K101042.

Who is the listed applicant for BLADEVIEW?

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

What is the FDA product code for BLADEVIEW?

The FDA product code for BLADEVIEW is KPR.

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Related Devices (Code: KPR)

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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