Cleared Special

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)

K220895 · Stryker · General & Plastic Surgery

Apr 2022

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K220895 is an FDA 510(k) clearance for the 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130), a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on April 22, 2022, 25 days after receiving the submission on March 28, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K220895 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2022
Decision Date	April 22, 2022
Days to Decision	25 days
Submission Type	Special
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).