Cleared Traditional

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes

K211202 · Stryker · Neurology

Aug 2021

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K211202 is an FDA 510(k) clearance for the 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on August 6, 2021, 106 days after receiving the submission on April 22, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K211202 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2021
Decision Date	August 06, 2021
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1480
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).