Cleared Traditional

VersaOne Reusable Positioning Trocar System

K201805 · Covidien · General & Plastic Surgery

Aug 2020

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K201805 is an FDA 510(k) clearance for the VersaOne Reusable Positioning Trocar System, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on August 26, 2020, 56 days after receiving the submission on July 1, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K201805 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2020
Decision Date	August 26, 2020
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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).