Hemorrhage Occluder Pin

FDA 510(k) K040109 · Tools For Surgery, LLC

Substantially Equivalent

510(k) numberK040109

Submission

Device name
Hemorrhage Occluder Pin
Applicant
Tools For Surgery, LLC
Stony Brook, NY, US
Received
January 20, 2004
Decision date
March 25, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GDW – Staple, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4750
Specialty
General, Plastic Surgery
Implant
Yes

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K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…GDW · Traditional Covidien (Part of Medtronic)04/10/2026SE
K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler…GDW · Traditional Ethicon Endo-Surgery, LLC12/17/2025SE
K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional Ethicon Endo-Surgery, LLC05/14/2025SE
K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler…GDW · Traditional Ethicon Endo-Surgery, LLC02/25/2025SE
K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional Ethicon Endo-Surgery, LLC10/28/2024SE
K242679Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special Fengh Medical Co., Ltd.10/04/2024SE
K222487Anika Tissue Tack Fixation SystemGDW · Traditional Anika Therapeutics, Inc.05/08/2023SE
K222210AEON Endoscopic StaplerGDW · Traditional Lexington Medical, Inc.04/21/2023SE
K223760ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™…GDW · Traditional Ethicon Endo-Surgery03/15/2023SE

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K220218Siren SGTKNT · Traditional 05/18/2022SE
K040110Easy Loop, Model EZL-01EZP · Traditional 03/24/2004SE

Questions and answers

When was Hemorrhage Occluder Pin cleared by the FDA?

Hemorrhage Occluder Pin (K040109) received a 510(k) decision of Substantially Equivalent on March 25, 2004, 65 days after the submission was received.

What is the product code of K040109?

The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.