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510(k) K913293

QUICK SEEDER by Mick Radio-Nuclear Instruments, Inc. — Product Code IWJ

K913293 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "QUICK SEEDER". The FDA issued a decision of Substantially Equivalent on October 13, 1992. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1992
Date Received
July 24, 1991
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 Mick Radio-Nuclear Instruments, Inc.

  • K230155 — Mick Valencia Applicator Set (August 30, 2023)
  • K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Appl (February 28, 2020)
  • K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template (May 31, 2016)
  • K142597 — Vienna System (February 19, 2015)
  • K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (December 14, 2012)
  • K063382 — HDR CT COMPATIBLE SPLIT RING APPLICATOR (December 26, 2006)
  • K063381 — CT COMPATIBLE F/S/D APPLICATORS (December 22, 2006)
  • K052351 — HDR IORT SHIELDED APPLICATOR (October 17, 2005)
  • K051423 — MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (July 1, 2005)
  • K040704 — MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLI (June 18, 2004)

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