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FDA 510(k)

STAYFUSE

K-Number: K990804 · 1999-04-29

ApplicantPioneer Surgical Technology
Decision Date1999-04-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAYFUSE 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 1999-04-29 under 510(k) number K990804. 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?

STAYFUSE is a medical device that received FDA 510(k) clearance on 1999-04-29. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K990804.

When did STAYFUSE receive FDA 510(k) clearance?

STAYFUSE received FDA 510(k) clearance on 1999-04-29, under 510(k) number K990804.

Who is the listed applicant for STAYFUSE?

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?

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

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Other records listing Pioneer Surgical Technology 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.

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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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