Home / 510(k) Clearances / K974118

510(k) K974118

WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET by Worldwide Medical Technologies, LLC — Product Code IWJ

K974118 is an FDA 510(k) premarket notification submitted by Worldwide Medical Technologies, LLC for the device "WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET". The FDA issued a decision of Substantially Equivalent on January 23, 1998. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Worldwide Medical Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1998
Date Received
October 31, 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 by Worldwide Medical Technologies, LLC

  • K062214 — BRACHYSCIENCES STRANDPORT (March 1, 2007)
  • K023179 — READI-STRAND, MODEL PSSTRAND (July 2, 2003)
  • K022705 — READI-STRAND, MODEL PSSTRAND (June 9, 2003)
  • K022389 — READI-LOAD SYSTEM, MODEL PSS 1820RL (May 6, 2003)
  • K020641 — SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 (October 29, 2002)
  • K020337 — READI-STRAND; MODEL PSSTRAND (July 29, 2002)
  • K020867 — BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL (May 20, 2002)
  • K991344 — WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS (November 5, 1999)
  • K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (July 31, 1998)
  • K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (June 25, 1998)

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)
  • 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)
  • K961377 — MANAN PROSTATE LOCKING INTRODUCER SET (July 3, 1996)

FDA data resources