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FDA 510(k)

SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE

K-Number: K020352 · 2002-02-26

ApplicantUnitedstates Surgical
Decision Date2002-02-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Unitedstates Surgical. It received FDA 510(k) clearance on 2002-02-26 under 510(k) number K020352. 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 SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE?

SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE is a medical device that received FDA 510(k) clearance on 2002-02-26. The listed applicant is Unitedstates Surgical. The 510(k) number is K020352.

When did SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE receive FDA 510(k) clearance?

SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE received FDA 510(k) clearance on 2002-02-26, under 510(k) number K020352.

Who is the listed applicant for SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE?

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

What is the FDA product code for SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE?

The FDA product code for SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE is HWC. This falls under the Cardiovascular category.

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Other records listing Unitedstates Surgical 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

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