Home / 510(k) Clearances / K962273

510(k) K962273

MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST by Marlo Surgical Technology — Product Code MFD

K962273 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST". The FDA issued a decision of Substantially Equivalent on July 31, 1996. 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
July 31, 1996
Date Received
June 13, 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 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)
  • 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)
  • K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (October 23, 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