510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000278Substantially Equivalent

Vivant Medical Biopsy Marker System

Vivant Medical, Inc., Portola Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000278 is the FDA 510(k) clearance record for VIVANT MEDICAL BIOPSY MARKER SYSTEM, a class II device, cleared for Vivant Medical, Inc. on under FDA product code FZP (Clip, Implantable). FDA records list 10 510(k) clearances for Vivant Medical, Inc., from to . As of , FDA records show no recalls naming K000278.

Clearance record

Decision date
Received
(144 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Vivant Medical, Inc. 3210-B Alpine Rd., Portola Valley CA
510(k) summary
Summary
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260