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 Voice Control, Connected OR Hub with Device Control

K-Number: K201434 · 2020-07-28

ApplicantStryker
Decision Date2020-07-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Connected OR Hub with Voice Control, Connected OR Hub with Device Control is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2020-07-28 under approval number K201434. 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 Voice Control, Connected OR Hub with Device Control?

Connected OR Hub with Voice Control, Connected OR Hub with Device Control is a medical device that received FDA 510(k) clearance on 2020-07-28. It is manufactured by Stryker. The 510(k) number is K201434.

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

Connected OR Hub with Voice Control, Connected OR Hub with Device Control received FDA 510(k) clearance on 2020-07-28, under approval number K201434.

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

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

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

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

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING 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

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

K161821Stryker Universal Mesh K162310XBraid TT Suture Tape K162262Tritanium® PL Cage K160955Tritanium® PL Cage K153248PEEK Customized Cranial Implant K153508Stryker CMF MEDPOR Customized Implant

View all 64 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.

↑