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FDA 510(k)

SURGICAL DYNAMICS MENISCAL STAPLE

K-Number: K013890 · 2001-12-11

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2001-12-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICAL DYNAMICS MENISCAL STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 2001-12-11 under 510(k) number K013890. 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 MENISCAL STAPLE?

SURGICAL DYNAMICS MENISCAL STAPLE is a medical device that received FDA 510(k) clearance on 2001-12-11. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K013890.

When did SURGICAL DYNAMICS MENISCAL STAPLE receive FDA 510(k) clearance?

SURGICAL DYNAMICS MENISCAL STAPLE received FDA 510(k) clearance on 2001-12-11, under 510(k) number K013890.

Who is the listed applicant for SURGICAL DYNAMICS MENISCAL STAPLE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL DYNAMICS MENISCAL STAPLE?

The FDA product code for SURGICAL DYNAMICS MENISCAL STAPLE is HWC. This falls under the Cardiovascular category.

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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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