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510(k) K021438

INSEMINATION CATHETER, MODEL 320301 by Labotect Labor-Technik Gottingen — Product Code MFD

K021438 is an FDA 510(k) premarket notification submitted by Labotect Labor-Technik Gottingen for the device "INSEMINATION CATHETER, MODEL 320301". The FDA issued a decision of Substantially Equivalent on July 16, 2002. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Labotect Labor-Technik Gottingen has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2002
Date Received
May 6, 2002
Clearance Type
Abbreviated
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 Labotect Labor-Technik Gottingen

  • K003056 — OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOP (December 13, 2000)
  • K000950 — EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 (May 12, 2000)

Other clearances for product code MFD

  • 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)
  • K963031 — GENXCATHETER (October 21, 1996)

FDA data resources