Cleared Traditional

Sutter RaVoR Bipolar Electrodes

K191732 · Sutter Medizintechnik GmbH · Ear, Nose, Throat

Aug 2019

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K191732 is an FDA 510(k) clearance for the Sutter RaVoR Bipolar Electrodes, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Sutter Medizintechnik GmbH (Freiburg, DE). The FDA issued a Cleared decision on August 30, 2019, 63 days after receiving the submission on June 28, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K191732 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2019
Decision Date	August 30, 2019
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
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).