Home / 510(k) Clearances / K050090

510(k) K050090

GEL MARK V by Senorx, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2005
Date Received
January 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Senorx, Inc.

  • K233220 — EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver ( (October 27, 2023)
  • K210654 — EnCor Breast Biopsy Probe with Rinse Tube (March 31, 2021)
  • K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer (July 19, 2016)
  • K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER (June 27, 2013)
  • K093512 — ENCOR BREAST BIOPSY SYSTEM (November 20, 2009)
  • K092323 — CONTURA CAVITY MAINTENANCE CATHETER (August 19, 2009)
  • K082264 — CONTURA LUMEN MARKER (September 12, 2008)
  • K081085 — STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS (August 1, 2008)
  • K081170 — PROSTATE TISSUE MARKER (May 28, 2008)
  • K081079 — CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY (May 2, 2008)

Other clearances for product code NEU

  • K253761 — HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Bre (January 23, 2026)
  • K253888 — MOLLI 2 System (December 31, 2025)
  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) (December 12, 2025)
  • K251748 — MammoSTAR Biopsy Site Identifier (July 23, 2025)
  • K243642 — UltraCor™ Twirl™ Breast Tissue Marker (March 24, 2025)
  • K233639 — SmartClip Secure Soft Tissue Marker (December 20, 2024)
  • K240429 — Trilogy Tissue Marker (November 7, 2024)
  • K234149 — MOLLI 2 System (September 26, 2024)
  • K240042 — MOLLI 2 System (September 25, 2024)