Cleared Special

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

K230886 · Stryker Endoscopy · General & Plastic Surgery

Jun 2023

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K230886 is an FDA 510(k) clearance for the Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on June 21, 2023, 82 days after receiving the submission on March 31, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K230886 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2023
Decision Date	June 21, 2023
Days to Decision	82 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).