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FDA 510(k)

STAYFUSE GT-IP

K-Number: K022726 · 2002-09-06

ApplicantPioneer Surgical Technology
Decision Date2002-09-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAYFUSE GT-IP is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology. It received FDA 510(k) clearance on 2002-09-06 under 510(k) number K022726. 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 STAYFUSE GT-IP?

STAYFUSE GT-IP is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K022726.

When did STAYFUSE GT-IP receive FDA 510(k) clearance?

STAYFUSE GT-IP received FDA 510(k) clearance on 2002-09-06, under 510(k) number K022726.

Who is the listed applicant for STAYFUSE GT-IP?

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

What is the FDA product code for STAYFUSE GT-IP?

The FDA product code for STAYFUSE GT-IP is HWC. This falls under the Cardiovascular category.

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Other records listing Pioneer Surgical Technology as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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