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510(k) K915253

IR-192 IMPLANT, MODIFICATION by Omnitron Intl., Inc. — Product Code IWA

K915253 is an FDA 510(k) premarket notification submitted by Omnitron Intl., Inc. for the device "IR-192 IMPLANT, MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 27, 1992. The device falls under product code IWA (Source, Wire, Iridium, Radioactive), a Class II device regulated under 21 CFR 892.5730. Omnitron Intl., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1992
Date Received
November 18, 1991
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 Omnitron Intl., Inc.

  • K901615 — PULMOCATH INTRABRONCHIAL CATHETER (November 27, 1992)
  • K923130 — IR-192 IMPLANT -- MODIFICATION (September 21, 1992)
  • K920431 — OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE (May 29, 1992)
  • K913908 — OMNITRON GYN APPLICATOR SYSTEM (March 6, 1992)
  • K911775 — OMNICATH IMPLANTED CATHETER AND DEPOT (May 8, 1991)
  • K881665 — OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR (August 11, 1988)

Other clearances for product code IWA

  • 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)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)

FDA data resources