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FDA 510(k)

STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS

K-Number: K071157 · 2007-09-17

ApplicantStryker Endoscopy
Decision Date2007-09-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2007-09-17 under 510(k) number K071157. 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 PEEK AND TITANIUM SOFT EYELET ANCHORS?

STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS is a medical device that received FDA 510(k) clearance on 2007-09-17. The listed applicant is Stryker Endoscopy. The 510(k) number is K071157.

When did STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS receive FDA 510(k) clearance?

STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS received FDA 510(k) clearance on 2007-09-17, under 510(k) number K071157.

Who is the listed applicant for STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS?

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 PEEK AND TITANIUM SOFT EYELET ANCHORS?

The FDA product code for STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS 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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