Cleared Special

Stryker Arthroscope

K202659 · Stryker · Orthopedic

Dec 2020

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K202659 is an FDA 510(k) clearance for the Stryker Arthroscope, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on December 1, 2020, 78 days after receiving the submission on September 14, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K202659 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2020
Decision Date	December 01, 2020
Days to Decision	78 days
Submission Type	Special
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).