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510(k) K944522

MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT by Medical Device Technologies, Inc. — Product Code IWJ

K944522 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT". The FDA issued a decision of Substantially Equivalent on February 24, 1995. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1995
Date Received
September 16, 1994
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 Medical Device Technologies, Inc.

  • K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (August 27, 2010)
  • K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (January 26, 2006)
  • K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (August 30, 2005)
  • K050873 — CANALIZER HYDROPHILIC GUIDE WIRE (May 26, 2005)
  • K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (February 11, 2005)
  • K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (September 30, 2004)
  • K040427 — FIBREX CATHETER PATENCY DEVICE (May 3, 2004)
  • K031442 — PBN GUIDEWIRES (August 13, 2003)
  • K021606 — EN-SNARE ENDOVASCULAR SNARE AND CATHETER (May 31, 2002)
  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)

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