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510(k) K940176

ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION by Ackrad Laboratories — Product Code MFD

K940176 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION". The FDA issued a decision of Substantially Equivalent on April 23, 1996. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Ackrad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
January 11, 1994
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 Ackrad Laboratories

  • K021272 — SIB CATHETER, MODEL 61-7005 (May 21, 2002)
  • K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TR (April 24, 2002)
  • K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (April 16, 2002)
  • K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (April 9, 1997)
  • K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 8, 1996)
  • K952542 — ACKRAD ESOPHAGEAL BALLOON CATHETER SET (April 23, 1996)
  • K953034 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 29, 1995)
  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)
  • K911780 — INFANT NASAL CANNULAE ASSEMBLY, MODIFIED (June 24, 1991)

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