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510(k) K984306

`THE INSEMINATOR' (PROPOSED) by Wallach Surgical Devices, Inc. — Product Code MFD

K984306 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "`THE INSEMINATOR' (PROPOSED)". The FDA issued a decision of Substantially Equivalent on March 1, 1999. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Wallach Surgical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1999
Date Received
December 2, 1998
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 Wallach Surgical Devices, Inc.

  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K020711 — WALLACH LOOP ELECTRODE (June 3, 2002)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (September 29, 1999)
  • K991669 — PMS 750 FINGERSWITCH (August 12, 1999)
  • K983840 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (May 20, 1999)
  • K983208 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (February 22, 1999)
  • K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM (June 11, 1997)
  • K963348 — WALLACH INTEGRATION UNIT (March 19, 1997)
  • K950630 — WALLACH DIGITAL IMAGING SYSTEM (November 22, 1995)

Other clearances for product code MFD

  • K021438 — INSEMINATION CATHETER, MODEL 320301 (July 16, 2002)
  • K012935 — THECURVE, ITEM 507 (October 11, 2001)
  • 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