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510(k) K040238

SOFTSEAL HSG CATHETER by Modern Medical Equipment Mfg., Ltd. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2004
Date Received
January 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Modern Medical Equipment Mfg., Ltd.

  • K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM (May 19, 2010)
  • K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODES (January 15, 2010)
  • K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT (September 14, 2007)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K050842 — AGCEL WOUND DRESSING,AGCEL BURN DRESSING (August 2, 2006)
  • K043036 — NON-STICK ELECTRODE (May 6, 2005)
  • K033095 — SMOKE EVACUATION ATTACHEMENT (November 17, 2004)
  • K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (June 15, 2004)
  • K032327 — MODERN MEDICAL BIPOLAR FORCEPS (June 15, 2004)
  • K033003 — SUCTION COAGULATOR (May 13, 2004)

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  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K222798 — Rejoni Intrauterine Catheter (December 16, 2022)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
  • K220202 — Uterine ElevatOR PRO with OccludOR Balloon (March 31, 2022)
  • K212505 — DUMI ManipulatOR (January 10, 2022)
  • K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (March 29, 2019)