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510(k) K071550

PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS by Cp Medical — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2007
Date Received
June 6, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Cp Medical

  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K094028 — CP-FIBER (ORTHOFIBER) (March 18, 2010)
  • K072229 — MONOSWIFT (October 5, 2007)
  • K060987 — OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (November 2, 2006)
  • K041894 — ORTHOFIBER (September 17, 2004)
  • K034062 — CP SLEEVE AND RIVER SLEEVE (January 30, 2004)
  • K024372 — CP MEDICAL BONE WAX (June 19, 2003)
  • K030786 — MONO-SWIFT (May 6, 2003)
  • K030351 — STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (March 28, 2003)
  • K023710 — VISORB SWIFT (January 17, 2003)

Other clearances for product code KXK

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  • K242818 — IsoSphere (July 15, 2025)
  • K223465 — RadianceTx Radionuclide Brachytherapy Source (January 11, 2023)
  • K221539 — GammaTile (November 9, 2022)
  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (May 29, 2020)
  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K190296 — GammaTile (March 13, 2019)
  • K180515 — GammaTile (July 6, 2018)