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510(k) K964848

WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM by Marlow Surgical Technologies, Inc. — Product Code MFD

K964848 is an FDA 510(k) premarket notification submitted by Marlow Surgical Technologies, Inc. for the device "WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM". The FDA issued a decision of Substantially Equivalent on January 16, 1997. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Marlow Surgical Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1997
Date Received
December 3, 1996
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 Marlow Surgical Technologies, Inc.

  • K944563 — FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS (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)
  • K963031 — GENXCATHETER (October 21, 1996)

FDA data resources