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510(k) K910577

EDWARDS-WALLACE BOURNE HALL CATHETER by Marlo Surgical Technology — Product Code MFD

K910577 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "EDWARDS-WALLACE BOURNE HALL CATHETER". The FDA issued a decision of Substantially Equivalent on May 9, 1991. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1991
Date Received
February 11, 1991
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 Marlo Surgical Technology

  • K960810 — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35M (October 21, 1996)
  • K962273 — MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST (July 31, 1996)
  • K924611 — IRRIGATION PUMP AND TUBING SET (June 30, 1994)
  • K932634 — NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES (February 25, 1994)
  • K932832 — PRIMUS INSULATED FORCEPS (February 25, 1994)
  • K920611 — MARLOW LAPAROSCOPIC GRASPING FORCEP (April 20, 1993)
  • K914153 — OTT INSUFFLATOR FILTER PLUS/TUBING SET (April 2, 1992)
  • K914869 — MARLOW LAPAROSCOPIC SCISSORS (January 15, 1992)
  • K913954 — MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS (December 18, 1991)
  • K914872 — MARLOW SUCTION/IRRIGATION PROBES (November 19, 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