510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K072913Substantially Equivalent

Securmark Biopsy Site Identification System

Suros Surgical Systems, Inc. A Hologic Company, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072913 is the FDA 510(k) clearance record for SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM, a class II device, cleared for Suros Surgical Systems, Inc. A Hologic Company on under FDA product code NEU (Marker, Radiographic, Implantable). FDA records list 2 510(k) clearances for Suros Surgical Systems, Inc. A Hologic Company, from to . As of , FDA records show no recalls naming K072913.

Clearance record

Decision date
Received
(84 days to decision)
Product code
NEU Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Suros Surgical Systems, Inc. A Hologic Company 6100 Technology Center Dr., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEU

Trailing 12 months
4 clearances under product code NEU in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NEU, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260