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510(k) K954215

MINIGUARD by Advanced Surgical Intervention, Inc. — Product Code MNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1996
Date Received
September 8, 1995
Clearance Type
Traditional
Expedited Review
Yes
Third Party Review
No

Device Classification

Device Name
External Urethral Occluder, Urinary Incontinence-Control, Female
Device Class
Class I
Regulation Number
876.5160
Review Panel
GU
Submission Type

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.

Other clearances by Advanced Surgical Intervention, Inc.

  • K926110 — ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT (July 8, 1993)
  • K930361 — ASI CYSTOLASE LASER CYSTOSCOPE (April 29, 1993)
  • K921990 — ASI UROPLASTY LASER CYSTOSCOPE (October 28, 1992)
  • K902585 — UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (August 27, 1990)
  • K901336 — ASI HEMOSTASIS CATHETER (June 20, 1990)
  • K896713 — ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. (May 24, 1990)
  • K895182 — ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY (October 24, 1989)
  • K874530 — URETHRAL DILATOR ENDOSCOPE (January 27, 1988)

Other clearances for product code MNG

  • K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (April 30, 2001)
  • K983164 — RESTORE (AKA RE/STOR) (March 5, 1999)
  • K974600 — UROMED PATCH (March 31, 1998)
  • K974645 — FEMASSIST FLEXIBLE (February 12, 1998)
  • K971359 — RESTORE (A.K.A. CAPSURE) (November 14, 1997)
  • K963858 — FEMASSIST URINARY DEVICE (October 21, 1997)