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Hemorrhage Occluder Pin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040109

by Tools For Surgery, Llc

Identifiers

510(k) Number
K040109 FDA 510(k)
FDA Product Code
GDW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4750 FDA 510(k)
Regulation Number
878.4750 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hemorrhage Occluder Pin is an implantable staple used to control localized severe hemorrhage from the sacral area during pelvic surgery. It is indicated for use when other techniques such as cautery, sutures, or clamping are judged ineffective. The device is designed to occlude presacral venous bleeding in colorectal and gynecological procedures.

The device is supplied sterile and is intended for single use. It is constructed from titanium and includes a shaft length of 7mm. It is classified as a Class II medical device under product code GDW and is regulated under regulation number 878.4750. Storage conditions should follow standard sterile device handling guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF IU-43E,INSTRUCTIONSFORUSE,HOP-AP - toolsforsurgery.com, TOOLS FOR SURGERY, LLC HOP-AP Hemorrhage Occluder Pin with Applicator, Welcome | Hemorrhage Occluder Pin | Surgin Inc., Hemorrhage Occluder Pin with Applicator — FDA Class II Medical Device ..., Hemorrhage Occluder Pin (CR1007) | Surgin Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tools For Surgery, Llc

Sources (1)

  • FDA 510(k) K040109 24 fields · synced Sep 22, 2026