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510(k) K971541

VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON by Hollister, Inc. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1997
Date Received
April 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

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  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (April 12, 2005)
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  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (March 19, 2002)
  • K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (March 5, 2002)
  • K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (January 14, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (January 7, 2002)

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