FDA 510(k)

HEMORRHAGE OCCLUDER PIN

K-Number: K040109 · 2004-03-25

Decision Date2004-03-25

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEMORRHAGE OCCLUDER PIN is the device name listed in this FDA 510(k) record. The listed applicant is Tools For Surgery, LLC. It received FDA 510(k) clearance on 2004-03-25 under 510(k) number K040109. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMORRHAGE OCCLUDER PIN?

HEMORRHAGE OCCLUDER PIN is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Tools For Surgery, LLC. The 510(k) number is K040109.

When did HEMORRHAGE OCCLUDER PIN receive FDA 510(k) clearance?

HEMORRHAGE OCCLUDER PIN received FDA 510(k) clearance on 2004-03-25, under 510(k) number K040109.

Who is the listed applicant for HEMORRHAGE OCCLUDER PIN?

The FDA 510(k) record lists Tools For Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMORRHAGE OCCLUDER PIN?

The FDA product code for HEMORRHAGE OCCLUDER PIN is GDW.

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Related Devices (Code: GDW)

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.