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FDA 510(k)

DUET SUTURE ANCHOR

K-Number: K020056 · 2002-06-26

ApplicantBionx Implants, Ltd.
Decision Date2002-06-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUET SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Ltd.. It received FDA 510(k) clearance on 2002-06-26 under 510(k) number K020056. 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 DUET SUTURE ANCHOR?

DUET SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2002-06-26. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K020056.

When did DUET SUTURE ANCHOR receive FDA 510(k) clearance?

DUET SUTURE ANCHOR received FDA 510(k) clearance on 2002-06-26, under 510(k) number K020056.

Who is the listed applicant for DUET SUTURE ANCHOR?

The FDA 510(k) record lists Bionx Implants, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUET SUTURE ANCHOR?

The FDA product code for DUET SUTURE ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Bionx Implants, Ltd. as applicant

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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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