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510(k) K960148

CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT by Cabot Medical Corp. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Cabot Medical Corp.

  • K946109 — CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS (November 21, 1995)
  • K951972 — CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SH (July 21, 1995)
  • K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (July 11, 1995)
  • K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (April 19, 1995)
  • K934115 — 3000 ELECTRONIC INSUFFLATOR MODIFICATION (March 15, 1995)
  • K932293 — CABOT MEDICAL BIPOLAR CUTTING FORCEPS (July 27, 1994)
  • K930954 — THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV (June 30, 1994)
  • K932626 — CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB (June 8, 1994)
  • K935786 — CORSON AND NEZHAT SUCTION/IRRIGATION PROBES (May 19, 1994)
  • K924631 — CABOT MEDICAL UTERINE RESECTOSCOPE (May 16, 1994)

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