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510(k) K932993

INTRAUTERINE CATHETER AND INTRODUCER by Conceptus, Inc. — Product Code MFD

K932993 is an FDA 510(k) premarket notification submitted by Conceptus, Inc. for the device "INTRAUTERINE CATHETER AND INTRODUCER". The FDA issued a decision of Substantially Equivalent on January 6, 1995. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Conceptus, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1995
Date Received
June 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Intrauterine Insemination
Device Class
Class II
Regulation Number
884.5250
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)
  • 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)
  • K933723 — CONCEPTUS UTERINE CATHETER (December 27, 1994)
  • K933981 — CERVICAL CATHETER (December 27, 1994)

Other clearances for product code MFD

  • K021438 — INSEMINATION CATHETER, MODEL 320301 (July 16, 2002)
  • K012935 — THECURVE, ITEM 507 (October 11, 2001)
  • K984306 — `THE INSEMINATOR' (PROPOSED) (March 1, 1999)
  • K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETER (January 14, 1999)
  • K982628 — MEDWORKS INSEMINATION CATHETER (August 21, 1998)
  • K980061 — EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATIO (March 2, 1998)
  • K972823 — MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER (October 10, 1997)
  • K972245 — TOM CAT F.L., TOM CAT S.L. (August 6, 1997)
  • K970750 — MICROSPAN INSEMINATION SYSTEM (May 5, 1997)
  • K964848 — WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (January 16, 1997)

FDA data resources