Home / 510(k) Clearances / K850163

510(k) K850163

IRIDIUM 192 WIRES by Syncor Intl. Corp. — Product Code IWA

K850163 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "IRIDIUM 192 WIRES". The FDA issued a decision of Substantially Equivalent on March 26, 1985. The device falls under product code IWA (Source, Wire, Iridium, Radioactive), a Class II device regulated under 21 CFR 892.5730. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1985
Date Received
January 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Wire, Iridium, Radioactive
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Syncor Intl. Corp.

  • K945825 — SECURE SAFETY INSERT (April 10, 1995)
  • K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (September 19, 1985)
  • K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 (August 21, 1985)
  • K850433 — CESIUM 137 ENDOMETRIAL SOURCE (August 21, 1985)
  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
  • K851033 — SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (June 21, 1985)
  • K844735 — PTH-RIA (April 29, 1985)
  • K850208 — FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS (March 26, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)

Other clearances for product code IWA

  • K915253 — IR-192 IMPLANT, MODIFICATION (February 27, 1992)
  • K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD (September 29, 1989)
  • K874895 — IR-192 IMPLANT (February 25, 1988)
  • K850382 — IRIDIUM SEEDS (August 15, 1985)
  • K844248 — IR-192 IMPLANT (April 10, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)

FDA data resources