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FDA 510(k)

PhotonBlade

K-Number: K162053 · 2016-09-15

ApplicantInvuity, Inc.
Decision Date2016-09-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PhotonBlade is a medical device manufactured by Invuity, Inc.. It received FDA 510(k) clearance on 2016-09-15 under approval number K162053. 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?

PhotonBlade is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Invuity, Inc.. The 510(k) number is K162053.

When was PhotonBlade approved by the FDA?

PhotonBlade received FDA 510(k) clearance on 2016-09-15, under approval number K162053.

What company makes PhotonBlade?

PhotonBlade is manufactured by Invuity, Inc..

What is the FDA product code for PhotonBlade?

The FDA product code for PhotonBlade is GEI.

Other Devices by Invuity, Inc.

K191583PhotonBlade with Smoke Evacuation

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Official Source

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