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

FDA 510(k)

Stryker SDC3 HD Information Management System with Wireless Device Control Capability

K-Number: K160332 · 2016-05-18

ApplicantStryker Endoscopy
Decision Date2016-05-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stryker SDC3 HD Information Management System with Wireless Device Control Capability is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2016-05-18 under 510(k) number K160332. 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 Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

Stryker SDC3 HD Information Management System with Wireless Device Control Capability is a medical device that received FDA 510(k) clearance on 2016-05-18. The listed applicant is Stryker Endoscopy. The 510(k) number is K160332.

When did Stryker SDC3 HD Information Management System with Wireless Device Control Capability receive FDA 510(k) clearance?

Stryker SDC3 HD Information Management System with Wireless Device Control Capability received FDA 510(k) clearance on 2016-05-18, under 510(k) number K160332.

Who is the listed applicant for Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

The FDA 510(k) record lists Stryker Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

The FDA product code for Stryker SDC3 HD Information Management System with Wireless Device Control Capability is GCJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyRECRUITING

Other records listing Stryker Endoscopy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownK253602Precision S 4K SinuscopeK261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemK2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityK260108L12 LED Light Source with AIMK254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

View all 25 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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.

↑