510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000060Substantially Equivalent

Gel Mark Biopsy Site Marker, Models Mkooo1, Mk0004, Mk0007

Senorx, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000060 is the FDA 510(k) clearance record for GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007, a class II device, cleared for Senorx, Inc. on under FDA product code GDW (Staple, Implantable). FDA records list 30 510(k) clearances for Senorx, Inc., from to . As of , FDA records show no recalls naming K000060.

Clearance record

Decision date
Received
(77 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Senorx, Inc. 13766 Alton Pkwy., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260