Cleared Special

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

K232157 · Stryker Corporation · General & Plastic Surgery

Aug 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K232157 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 Corporation (San Jose, US). The FDA issued a Cleared decision on August 18, 2023, 29 days after receiving the submission on July 20, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K232157 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2023
Decision Date	August 18, 2023
Days to Decision	29 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).