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510(k) K970443

HOLLISTER RETRACTED PENIS POUCH by Hollister, Inc. — Product Code EXI

K970443 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "HOLLISTER RETRACTED PENIS POUCH". The FDA issued a decision of Substantially Equivalent on February 25, 1997. The device falls under product code EXI (Device, Paste-On For Incontinence, Sterile), a Class I device regulated under 21 CFR 876.5250. Hollister, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1997
Date Received
February 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Paste-On For Incontinence, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Hollister, Inc.

  • K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT (April 17, 2013)
  • 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)

Other clearances for product code EXI

  • K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH (August 28, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K931277 — HOLLISTER PREMIUM URINE COLLECTOR (June 23, 1993)
  • K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION (June 22, 1993)
  • K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (February 5, 1992)
  • K915616 — URIHESIVE STRIP (January 23, 1992)

FDA data resources