UltraCor Twirl Breast Tissue Marker
FDA 510(k) K152510 · Bard Peripheral Vascular, Inc.
510(k) numberK152510
Submission
- Device name
- UltraCor Twirl Breast Tissue Marker
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- September 2, 2015
- Decision date
- May 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code NEU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | 08/14/2026SE |
| K260012 | UltraScore Focused Force PTA BalloonPNO · Special | 02/04/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | 12/12/2025SE |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument KitKNW · Special | 07/10/2025SE |
| K250219 | Dorado PTA Balloon Dilatation CatheterDQY · Traditional | 06/17/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | 03/24/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | 01/30/2025SE |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal…PNG · Traditional | 12/06/2024SE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special | 12/08/2023SE |
| K221440 | Liverty TIPS Access SetDYB · Traditional | 05/31/2022SE |
Questions and answers
When was UltraCor Twirl Breast Tissue Marker cleared by the FDA?
UltraCor Twirl Breast Tissue Marker (K152510) received a 510(k) decision of Substantially Equivalent on May 13, 2016, 254 days after the submission was received.
What is the product code of K152510?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.