FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOLLISTER RETRACTED PENIS POUCH
K Number: K970443
·
Decision Feb 25, 1997
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
6
Applicant Total
85
Review Days
20
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Basic Information
- Device Name
- HOLLISTER RETRACTED PENIS POUCH
- K Number
- K970443
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hollister, Inc.
- Date Received
- February 5, 1997
- Decision Date
- February 25, 1997
- Product Code
- EXI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EXI | Device, Paste-On For Incontinence, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXI), ordered by most recent decision date.
FEMALE EXTERNAL URINARY COLLECTION POUCH
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BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
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HOLLISTER PREMIUM URINE COLLECTOR
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CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
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FDA Class 1
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CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
URIHESIVE STRIP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Hollister, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123804 | INSTAFLO BOWEL CATHETER SYSTEM KIT | Apr 17, 2013 | Substantially Equivalent |
| K100273 | INSTAFLO BOWEL CATHETER SYSTEM KIT | Apr 22, 2010 | Unknown |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | Aug 20, 2009 | Substantially Equivalent |
| K083153 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 | Feb 4, 2009 | Unknown |
| K050483 | EVADRI BLADDER CONTROL SYSTEMS | Apr 12, 2005 | Substantially Equivalent |
| K040779 | RESTORE WOUND CLEANSER | May 17, 2004 | Substantially Equivalent |
| K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM | Mar 19, 2002 | Substantially Equivalent |
| K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE | Mar 5, 2002 | Substantially Equivalent |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | Jan 14, 2002 | Substantially Equivalent |
| K013345 | INCARE INTERMITTENT CATHETER | Jan 7, 2002 | Substantially Equivalent |