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510(k) K010166

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM by Imagyn Medical Technologies, Inc. — Product Code IWJ

K010166 is an FDA 510(k) premarket notification submitted by Imagyn Medical Technologies, Inc. for the device "IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 3, 2001. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Imagyn Medical Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2001
Date Received
January 18, 2001
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 Imagyn Medical Technologies, Inc.

  • K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (September 4, 2003)
  • K012706 — IM2001 PULSE OXIMETER (March 7, 2003)
  • K991526 — ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 (June 17, 1999)
  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K980291 — IMPOWER EXTERNAL VACUUM SYSTEM (March 11, 1998)
  • K974173 — ERECAID SYSTEM/STAY EREC SYSTEM (February 25, 1998)

Other clearances for product code IWJ

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

FDA data resources