Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007
FDA 510(k) K000060 · Senorx, Inc.
510(k) numberK000060
Submission
- Device name
- Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007
- Applicant
- Senorx, Inc.
Irvine, CA, US - Received
- January 10, 2000
- Decision date
- March 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver…KNW · Special | 10/27/2023SE |
| K210654 | EnCor Breast Biopsy Probe with Rinse TubeKNW · Special | 03/31/2021SE |
| K161805 | EnCor MRI Introducer Set, EnCor Probe IntroducerKNW · Special | 07/19/2016SE |
| K131654 | Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerNEU · Special | 06/27/2013SE |
| K093512 | Encor Breast Biopsy SystemKNW · Traditional | 11/20/2009SE |
| K092323 | Contura Cavity Maintenance CatheterJAQ · Traditional | 08/19/2009SE |
| K082264 | Contura Lumen MarkerJAQ · Traditional | 09/12/2008SESU |
| K081085 | Starchmark Biopsy Site Marker, Model STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSNEU · Traditional | 08/01/2008SE |
| K081170 | Prostate Tissue MarkerNEU · Traditional | 05/28/2008SE |
| K081079 | Contura MLB Source Applicator for BrachytherapyJAQ · Traditional | 05/02/2008SESU |
Questions and answers
When was Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007 cleared by the FDA?
Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007 (K000060) received a 510(k) decision of Substantially Equivalent on March 27, 2000, 77 days after the submission was received.
What is the product code of K000060?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.