FDA 510(k)

PhotonBlade with Smoke Evacuation

K-Number: K191583 · 2020-03-06

Decision Date2020-03-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PhotonBlade with Smoke Evacuation is a medical device manufactured by Invuity, Inc.. It received FDA 510(k) clearance on 2020-03-06 under approval 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. It is manufactured by Invuity, Inc.. The 510(k) number is K191583.

When was PhotonBlade with Smoke Evacuation approved by the FDA?

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

What company makes PhotonBlade with Smoke Evacuation?

PhotonBlade with Smoke Evacuation is manufactured by Invuity, Inc..

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

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

Related Clinical Trials

NCT03418402 Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System COMPLETED

Other Devices by Invuity, Inc.

K162053PhotonBlade

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.