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FDA 510(k)

STRYKER XCEL ANCHOR SYSTEM

K-Number: K023013 · 2003-02-26

ApplicantStryker Endoscopy
Decision Date2003-02-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER XCEL ANCHOR 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 2003-02-26 under 510(k) number K023013. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER XCEL ANCHOR SYSTEM?

STRYKER XCEL ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is Stryker Endoscopy. The 510(k) number is K023013.

When did STRYKER XCEL ANCHOR SYSTEM receive FDA 510(k) clearance?

STRYKER XCEL ANCHOR SYSTEM received FDA 510(k) clearance on 2003-02-26, under 510(k) number K023013.

Who is the listed applicant for STRYKER XCEL ANCHOR 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 XCEL ANCHOR SYSTEM?

The FDA product code for STRYKER XCEL ANCHOR SYSTEM is HWC. This falls under the Cardiovascular category.

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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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