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FDA 510(k)

STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM

K-Number: K121893 · 2012-09-05

ApplicantStryker Endoscopy
Decision Date2012-09-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2012-09-05 under 510(k) number K121893. 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?

STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-05. The listed applicant is Stryker Endoscopy. The 510(k) number is K121893.

When did STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2012-09-05, under 510(k) number K121893.

Who is the listed applicant for STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM?

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?

The FDA product code for STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM is GCJ.

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Related Devices (Code: 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.

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