Hemorrhage Occludor
FDA 510(k) K890447 · Surgeon Surgical Instrumentation, Inc.
510(k) numberK890447
Submission
- Device name
- Hemorrhage Occludor
- Applicant
- Surgeon Surgical Instrumentation, Inc.
Placentia, CA, US - Received
- January 27, 1989
- Decision date
- February 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
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| K954241 | Surgin Genisis PhacoemulsifierHQC · Traditional | 12/01/1995SE |
| K932281 | Verres NeedleGCT · Traditional | 08/06/1993SE |
| K922038 | CO2 Insufflation TubingHIF · Traditional | 10/13/1992SE |
| K904010 | Surgical Aspirator KitLFL · Traditional | 11/21/1990SE |
| K880543 | Uni-PortKYG · Traditional | 07/01/1988SE |
| K881232 | Surgin Eye ShieldHOY · Traditional | 04/13/1988SE |
| K861203 | Multi-SpikeKYG · Traditional | 04/28/1986SE |
| K852229 | Sterile Eye Packs or Trays · Traditional | 06/07/1985SE |
| K830859 | I/A KitGBX · Traditional | 05/02/1983SE |
Questions and answers
When was Hemorrhage Occludor cleared by the FDA?
Hemorrhage Occludor (K890447) received a 510(k) decision of Substantially Equivalent on February 23, 1989, 27 days after the submission was received.
What is the product code of K890447?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.