Cleared Traditional

Alexis Contained Extraction System

K211043 · Applied Medical Resources Corporation · Obstetrics & Gynecology

Mar 2022

Decision

357d

Days

Class 2

Risk

About This 510(k) Submission

K211043 is an FDA 510(k) clearance for the Alexis Contained Extraction System, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on March 31, 2022, 357 days after receiving the submission on April 8, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K211043 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2021
Decision Date	March 31, 2022
Days to Decision	357 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
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).