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510(k) K973786

NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE by Nw Radiation Therapy Products — Product Code IWJ

K973786 is an FDA 510(k) premarket notification submitted by Nw Radiation Therapy Products for the device "NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE". The FDA issued a decision of Substantially Equivalent on January 2, 1998. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1998
Date Received
October 6, 1997
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 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)
  • 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)
  • K961377 — MANAN PROSTATE LOCKING INTRODUCER SET (July 3, 1996)

FDA data resources