Ultraclip II MR
FDA 510(k) K041201 · Inrad
510(k) numberK041201
Submission
- Device name
- Ultraclip II MR
- Applicant
- Inrad
Kentwood, MI, US - Received
- May 7, 2004
- Decision date
- June 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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 |
More from Ethicon Endo-Surgery
| 510(k) | Device | Decision |
|---|---|---|
| K243886 | ExpressCore Biopsy DeviceKNW · Traditional | 04/29/2025SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | 11/07/2024SE |
| K183503 | EasyMark Tissue MarkerNEU · Traditional | 10/17/2019SE |
| K112945 | Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, With/Hilitier 18GAX10CM…KNW · Special | 11/03/2011SE |
| K093399 | Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520KNW · Traditional | 11/19/2009SE |
| K093256 | Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018KNW · Traditional | 11/17/2009SE |
| K090611 | Revolution Full Core BiopsyKNW · Traditional | 06/04/2009SE |
| K063238 | Ultraclip II Wing and Ultraclip II CoilNEU · Traditional | 01/30/2007SE |
| K042341 | Ultraclip II USNEU · Special | 09/20/2004SE |
| K000612 | Accucore Single Action Core Biopsy DeviceKNW · Traditional | 04/24/2000SE |
Questions and answers
When was Ultraclip II MR cleared by the FDA?
Ultraclip II MR (K041201) received a 510(k) decision of Substantially Equivalent on June 3, 2004, 27 days after the submission was received.
What is the product code of K041201?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.