Cleared Traditional

K201349 - Smith+Nephew Arthroscopes
(FDA 510(k) Clearance)

K201349 · Smith & Nephew · Orthopedic

Jul 2020

Decision

60d

Days

Class 2

Risk

K201349 is an FDA 510(k) clearance for the Smith+Nephew Arthroscopes, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on July 20, 2020, 60 days after receiving the submission on May 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K201349 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2020
Decision Date	July 20, 2020
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
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).