Cleared Traditional

PhotonBlade with Smoke Evacuation

K191583 · Invuity, Inc. · General & Plastic Surgery

Mar 2020

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K191583 is an FDA 510(k) clearance for the PhotonBlade with Smoke Evacuation, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Invuity, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 6, 2020, 266 days after receiving the submission on June 14, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K191583 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2019
Decision Date	March 06, 2020
Days to Decision	266 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).