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510(k) K914541

SPERM MAINTENANCE MEDIUM WITH GLYCEROL by Irvine Scientific — Product Code MFD

K914541 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "SPERM MAINTENANCE MEDIUM WITH GLYCEROL". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Irvine Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
October 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 Irvine Scientific

  • K160006 — Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit (May 4, 2016)
  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
  • K894405 — HTF WITH ALBUMIN (CATALOG NO. 9994) (September 22, 1989)
  • K894432 — MODIFIED HAM'S F-10 W/ALBUMIN (September 22, 1989)
  • K874668 — SPERM WASHING MEDIUM #9983 & MODIFIED #9984 (March 31, 1988)
  • K872203 — CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) (August 14, 1987)
  • K872088 — FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) (August 14, 1987)
  • K872102 — SPERM WASHING MEDIUM #9932 (July 16, 1987)
  • K871577 — HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES (July 15, 1987)
  • K861188 — SPERM CAPACITATION MEDIUM (January 6, 1987)

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