Vivant Medical Biopsy Marker System
FDA 510(k) K000278 · Vivant Medical, Inc.
510(k) numberK000278
Submission
- Device name
- Vivant Medical Biopsy Marker System
- Applicant
- Vivant Medical, Inc.
Portola Valley, CA, US - Received
- January 31, 2000
- Decision date
- June 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZP – Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K023311 | Loop Microwave Ablation ProbeGEI · Traditional | 04/09/2003SE |
| K022286 | Encircle Localization DeviceKNW · Traditional | 10/11/2002SE |
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Questions and answers
When was Vivant Medical Biopsy Marker System cleared by the FDA?
Vivant Medical Biopsy Marker System (K000278) received a 510(k) decision of Substantially Equivalent on June 23, 2000, 144 days after the submission was received.
What is the product code of K000278?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.