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510(k) K963743

MANAN PROSTATE UNI-LOCK by Manan Medical Products, Inc. — Product Code IWJ

K963743 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MANAN PROSTATE UNI-LOCK". The FDA issued a decision of Substantially Equivalent on December 6, 1996. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1996
Date Received
September 17, 1996
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 Manan Medical Products, Inc.

  • K052802 — MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE (November 1, 2005)
  • K011209 — MANAN SPRITACRE SPINAL NEEDLES (June 26, 2001)
  • K983620 — MANAN SPINAL NEEDLES (January 8, 1999)
  • K980536 — EPIDURAL NEEDLE (July 31, 1998)
  • K981386 — MANAN BLUNT NEEDLE (June 29, 1998)
  • K980211 — MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES (February 6, 1998)
  • K974446 — MANAN AUTOMATIC CUTTING NEEDLE (January 8, 1998)
  • K962977 — MRI COMPATIBLE BIOPSY NEEDLES (October 9, 1997)
  • K963767 — MANAN V.S. ACCESS NEEDLE/SET (May 16, 1997)
  • K961986 — MANAN D BAG (March 13, 1997)

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)
  • K951052 — WEEKS APPLICATOR (August 22, 1996)
  • K961377 — MANAN PROSTATE LOCKING INTRODUCER SET (July 3, 1996)

FDA data resources