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510(k) K123804

INSTAFLO BOWEL CATHETER SYSTEM KIT by Hollister, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2013
Date Received
December 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Hollister, Inc.

  • K100273 — INSTAFLO BOWEL CATHETER SYSTEM KIT (April 22, 2010)
  • K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 7208 (August 20, 2009)
  • 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)
  • 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)
  • K013141 — MICROGYN PLUS STIMULATION DEVICE (December 19, 2001)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)