Cleared Traditional

Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps

K191847 · Adeor Medical AG · General & Plastic Surgery

May 2020

Decision

317d

Days

Class 2

Risk

About This 510(k) Submission

K191847 is an FDA 510(k) clearance for the Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Adeor Medical AG (Unterhaching, DE). The FDA issued a Cleared decision on May 22, 2020, 317 days after receiving the submission on July 10, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K191847 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2019
Decision Date	May 22, 2020
Days to Decision	317 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).