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510(k) K912170

RADIOACTIVE IODINE-125 SOURCES by Best Industries — Product Code IWI

K912170 is an FDA 510(k) premarket notification submitted by Best Industries for the device "RADIOACTIVE IODINE-125 SOURCES". The FDA issued a decision of Substantially Equivalent on August 9, 1991. The device falls under product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. Best Industries has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Isotope, Sealed, Gold, Titanium, Platinum
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Best Industries

  • K933410 — IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF R (December 30, 1994)
  • K940121 — IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS (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)
  • K910862 — VARIOUS TEMPLATE APPLICATORS (April 18, 1991)

Other clearances for product code IWI

  • K973363 — NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL ME (July 2, 1998)
  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K874787 — MODIFIED PALLADIUM SEED MODEL 100 (December 22, 1987)
  • K852542 — PALLADIUM SEED MODEL 100 (January 14, 1986)

FDA data resources