FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PELVX INCONTINENCE DISH, MODEL 301-306
K Number: K990593
·
Decision May 24, 1999
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- PELVX INCONTINENCE DISH, MODEL 301-306
- K Number
- K990593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3575
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deschutes Medical Products, Inc.
- Date Received
- February 24, 1999
- Decision Date
- May 24, 1999
- Product Code
- HHW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHW | Pessary, Vaginal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Deschutes Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002329 | PELVX GELLHORN VAGINAL PESSARY 603-608 | Sep 18, 2000 | Substantially Equivalent |
| K994079 | REFLEX TREATMENT SYSTEM | Mar 1, 2000 | Substantially Equivalent |
| K974116 | PELVX INCONTINENCE RING | Apr 27, 1998 | Substantially Equivalent |
| K974117 | PELVX DONUT, PELVX CUBE | Apr 27, 1998 | Substantially Equivalent |
| K974115 | PELVX RING, PELVX RING WITH SUPPORT | Apr 27, 1998 | Substantially Equivalent |
| K934552 | PERIPUMP | Aug 9, 1995 | Substantially Equivalent |
| K951569 | SURGACTIVATOR | Jun 6, 1995 | Substantially Equivalent |