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510(k) K012935

THECURVE, ITEM 507 by Select Medical Systems, Inc. — Product Code MFD

K012935 is an FDA 510(k) premarket notification submitted by Select Medical Systems, Inc. for the device "THECURVE, ITEM 507". The FDA issued a decision of Substantially Equivalent on October 11, 2001. 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
October 11, 2001
Date Received
August 31, 2001
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.

  • K974819 — SELECTCELLS(TM) MINI (March 23, 1998)
  • K954099 — SELECT IUI (November 22, 1995)
  • 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)
  • 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)
  • K963031 — GENXCATHETER (October 21, 1996)

FDA data resources