Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Connected OR Hub with Device and Voice Control

K-Number: K212055 · 2021-12-16

ApplicantStryker Corporation
Decision Date2021-12-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Connected OR Hub with Device and Voice Control is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2021-12-16 under approval number K212055. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Connected OR Hub with Device and Voice Control?

Connected OR Hub with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Stryker Corporation. The 510(k) number is K212055.

When was Connected OR Hub with Device and Voice Control approved by the FDA?

Connected OR Hub with Device and Voice Control received FDA 510(k) clearance on 2021-12-16, under approval number K212055.

What company makes Connected OR Hub with Device and Voice Control?

Connected OR Hub with Device and Voice Control is manufactured by Stryker Corporation.

What is the FDA product code for Connected OR Hub with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control is GCJ.

Related Clinical Trials

NCT05341661 Butterfly Pivotal Study ACTIVE_NOT_RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Other Devices by Stryker Corporation

K162062AVAmax Vertebral Balloon, AVAflex Vertebral Balloon K160715AccuLIF TL and PL Cage K160978LITe BIO Delivery System K160050SERFAS 90-S Electrosurgical Probe K153407Stryker Neptune 3 Waste Management System K160693Neptune E-SEP Smoke Evacuation Pencil

View all 43 devices →

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑