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FDA 510(k)

STRYKER BIOZIP SUTURE ANCHOR

K-Number: K023192 · 2003-03-20

ApplicantStryker Endoscopy
Decision Date2003-03-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER BIOZIP SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K023192. 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 STRYKER BIOZIP SUTURE ANCHOR?

STRYKER BIOZIP SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Stryker Endoscopy. The 510(k) number is K023192.

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

STRYKER BIOZIP SUTURE ANCHOR received FDA 510(k) clearance on 2003-03-20, under 510(k) number K023192.

Who is the listed applicant for STRYKER BIOZIP SUTURE ANCHOR?

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

What is the FDA product code for STRYKER BIOZIP SUTURE ANCHOR?

The FDA product code for STRYKER BIOZIP SUTURE ANCHOR 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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