FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOLLISTER DRAINAGE POUCH
K Number: K801504
·
Decision Aug 12, 1980
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
2
Applicant Total
85
Review Days
46
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Basic Information
- Device Name
- HOLLISTER DRAINAGE POUCH
- K Number
- K801504
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hollister, Inc.
- Date Received
- June 27, 1980
- Decision Date
- August 12, 1980
- Product Code
- FON
- 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 |
|---|---|---|---|
| FON | Bag, Drainage, With Adhesive, Ostomy | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FON), ordered by most recent decision date.
BAG, DRAINAGEW/ADHESIVE; PROSTHESIS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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|---|---|---|---|
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| 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 |