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FDA 510(k)

DOUBLEPLAY SUTURE ANCHOR

K-Number: K061949 · 2006-09-25

ApplicantBiocomposites, Ltd.
Decision Date2006-09-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DOUBLEPLAY SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2006-09-25 under 510(k) number K061949. 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 DOUBLEPLAY SUTURE ANCHOR?

DOUBLEPLAY SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K061949.

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

DOUBLEPLAY SUTURE ANCHOR received FDA 510(k) clearance on 2006-09-25, under 510(k) number K061949.

Who is the listed applicant for DOUBLEPLAY SUTURE ANCHOR?

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

What is the FDA product code for DOUBLEPLAY SUTURE ANCHOR?

The FDA product code for DOUBLEPLAY SUTURE ANCHOR 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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