FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVADRI BLADDER CONTROL SYSTEMS
K Number: K050483
·
Decision Apr 12, 2005
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
85
Review Days
47
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EVADRI BLADDER CONTROL SYSTEMS
- K Number
- K050483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hollister, Inc.
- Date Received
- February 24, 2005
- Decision Date
- April 12, 2005
- Product Code
- KPI
- 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 |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPI), ordered by most recent decision date.
Pelvic Muscle Trainer (KM510, KM516B)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Well-Life Incontinence Stimulation System (WL-2405i(P))
FDA 510(k)
FDA Class 2
·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 |
| 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 |
| K013141 | MICROGYN PLUS STIMULATION DEVICE | Dec 19, 2001 | Substantially Equivalent |