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FDA 510(k)

PhotonBlade with Smoke Evacuation

K-Number: K191583 · 2020-03-06

ApplicantInvuity, Inc.
Decision Date2020-03-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PhotonBlade with Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Invuity, Inc.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K191583. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhotonBlade with Smoke Evacuation?

PhotonBlade with Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Invuity, Inc.. The 510(k) number is K191583.

When did PhotonBlade with Smoke Evacuation receive FDA 510(k) clearance?

PhotonBlade with Smoke Evacuation received FDA 510(k) clearance on 2020-03-06, under 510(k) number K191583.

Who is the listed applicant for PhotonBlade with Smoke Evacuation?

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

What is the FDA product code for PhotonBlade with Smoke Evacuation?

The FDA product code for PhotonBlade with Smoke Evacuation is GEI.

Other records listing Invuity, 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.

K162053PhotonBlade

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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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