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510(k) K940121

IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS by Best Industries — Product Code IWJ

K940121 is an FDA 510(k) premarket notification submitted by Best Industries for the device "IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS". The FDA issued a decision of Substantially Equivalent on December 30, 1994. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Best Industries has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1994
Date Received
January 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Manual
Device Class
Class I
Regulation Number
892.5650
Review Panel
RA
Submission Type

Other clearances by Best Industries

  • K933410 — IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF R (December 30, 1994)
  • K940119 — ROYAL MARSDEN GOLD GRAIN GUN (December 30, 1994)
  • K932242 — RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 (July 27, 1993)
  • K924290 — BEST INDUSTRIES CARTRIDGE & GUN (June 4, 1993)
  • K930570 — RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES (June 4, 1993)
  • K924261 — RADIOACTIVE CESIUM-131 SEEDS/SOURCES (June 4, 1993)
  • K912170 — RADIOACTIVE IODINE-125 SOURCES (August 9, 1991)
  • K910862 — VARIOUS TEMPLATE APPLICATORS (April 18, 1991)

Other clearances for product code IWJ

  • K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (December 3, 2001)
  • K980997 — PGK DEVICE (MODIFIED) (September 28, 1998)
  • K972554 — REGANES RADIONUCLIDE SEED MAGAZINE (February 17, 1998)
  • K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (January 27, 1998)
  • K974118 — WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (January 23, 1998)
  • K973786 — NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (January 2, 1998)
  • K973638 — N.I.T., INC. NEEDLE GUIDING TEMPLATE (December 23, 1997)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K963743 — MANAN PROSTATE UNI-LOCK (December 6, 1996)
  • K951052 — WEEKS APPLICATOR (August 22, 1996)

FDA data resources