Senomark Ultra Breast Tissue Marker
FDA 510(k) K123911 · C.R. Bard, Inc.
510(k) numberK123911
Submission
- Device name
- Senomark Ultra Breast Tissue Marker
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- December 19, 2012
- Decision date
- January 10, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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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| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
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| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
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Questions and answers
When was Senomark Ultra Breast Tissue Marker cleared by the FDA?
Senomark Ultra Breast Tissue Marker (K123911) received a 510(k) decision of Substantially Equivalent on January 10, 2013, 22 days after the submission was received.
What is the product code of K123911?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.