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510(k) K962587

CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM by Conceptus, Inc. — Product Code MKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1997
Date Received
July 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Falloposcope
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Conceptus, Inc.

  • K974028 — STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (January 21, 1998)
  • K972210 — RESECTOSCOPE SAFETY SHEATH (September 5, 1997)
  • K954164 — HYSTEROSCOPE (March 12, 1996)
  • K953314 — CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (July 28, 1995)
  • K932387 — CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL (March 6, 1995)
  • K932993 — INTRAUTERINE CATHETER AND INTRODUCER (January 6, 1995)
  • K933723 — CONCEPTUS UTERINE CATHETER (December 27, 1994)
  • K933981 — CERVICAL CATHETER (December 27, 1994)

Other clearances for product code MKO

  • K221965 — FemDx FalloView (March 17, 2023)
  • K974028 — STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (January 21, 1998)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)