FDA 510(k)

Stryker SDC3 HD Information Management System with Wireless Device Control Capability

K-Number: K160332 · 2016-05-18

Decision Date2016-05-18

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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

When was Stryker SDC3 HD Information Management System with Wireless Device Control Capability approved by the FDA?

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

What company makes Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

Stryker SDC3 HD Information Management System with Wireless Device Control Capability is manufactured by Stryker Endoscopy.

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.

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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.