Home / 510(k) Clearances / K974028

510(k) K974028

STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING by Conceptus, Inc. — Product Code MKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1998
Date Received
October 23, 1997
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.

  • K972210 — RESECTOSCOPE SAFETY SHEATH (September 5, 1997)
  • K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (January 31, 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)
  • K933981 — CERVICAL CATHETER (December 27, 1994)
  • K933723 — CONCEPTUS UTERINE CATHETER (December 27, 1994)

Other clearances for product code MKO

  • K221965 — FemDx FalloView (March 17, 2023)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)
  • K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (January 31, 1997)