Gel Mark IV
FDA 510(k) K040706 · Senorx, Inc.
510(k) numberK040706
Submission
- Device name
- Gel Mark IV
- Applicant
- Senorx, Inc.
Aliso Viejo, CA, US - Received
- March 18, 2004
- Decision date
- April 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| 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 IV cleared by the FDA?
Gel Mark IV (K040706) received a 510(k) decision of Substantially Equivalent on April 8, 2004, 21 days after the submission was received.
What is the product code of K040706?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.