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510(k) K013653

INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE by Hollister, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2002
Date Received
November 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

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  • K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (February 4, 2009)
  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (April 12, 2005)
  • K040779 — RESTORE WOUND CLEANSER (May 17, 2004)
  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (March 19, 2002)
  • K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (January 14, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (January 7, 2002)
  • K013141 — MICROGYN PLUS STIMULATION DEVICE (December 19, 2001)

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  • K213913 — leva Pelvic Health System (June 30, 2022)
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