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510(k) K922117

C-TRAK BIOPSY SYSTEM by Care Wise Medical Products Corp. — Product Code IZD

K922117 is an FDA 510(k) premarket notification submitted by Care Wise Medical Products Corp. for the device "C-TRAK BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 14, 1992. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Care Wise Medical Products Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1992
Date Received
May 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Uptake, Nuclear
Device Class
Class I
Regulation Number
892.1320
Review Panel
RA
Submission Type

Other clearances by Care Wise Medical Products Corp.

  • K982442 — C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (August 25, 1998)
  • K896588 — ONCOPROBE II SYSTEM (March 14, 1990)
  • K884770 — ONCOPROBE SYSTEM (January 4, 1989)

Other clearances for product code IZD

  • K133781 — DECLIPSESPECT LAPAROSCOPY (April 11, 2014)
  • K123917 — DECLIPSESPECT VIEWER (January 25, 2013)
  • K101887 — CONFIDENT SURGERY SUITE 300, MODEL CSS300 (March 22, 2011)
  • K013751 — HANDHELD GAMMA FINDER (HGF) (February 6, 2002)
  • K983768 — MODIFICATION TO GAMMA GUIDANCE SYSTEM (July 2, 1999)
  • K982442 — C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (August 25, 1998)
  • K971167 — NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (June 26, 1997)
  • K961321 — GAMMA GUIDANCE SYSTEM (February 10, 1997)
  • K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (September 13, 1996)
  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)

FDA data resources