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510(k) K954099

SELECT IUI by Select Medical Systems, Inc. — Product Code MFD

K954099 is an FDA 510(k) premarket notification submitted by Select Medical Systems, Inc. for the device "SELECT IUI". The FDA issued a decision of Substantially Equivalent on November 22, 1995. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Select Medical Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1995
Date Received
August 31, 1995
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 Select Medical Systems, Inc.

  • K012935 — THECURVE, ITEM 507 (October 11, 2001)
  • K974819 — SELECTCELLS(TM) MINI (March 23, 1998)
  • K954097 — SELECTCELLS STANDARD (November 21, 1995)
  • K954102 — SELECTMUCUS (November 21, 1995)
  • K942922 — SELECTA 20/60 CHEMISTRY ANALYZER (July 19, 1995)

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