FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROSTYM
K Number: K962009
·
Decision May 20, 1997
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
11
Review Days
363
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Basic Information
- Device Name
- UROSTYM
- K Number
- K962009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laborie Medical Technologies, Ltd.
- Date Received
- May 22, 1996
- Decision Date
- May 20, 1997
- 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 |
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Other Clearances by Laborie Medical Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | Jul 21, 2009 | Substantially Equivalent |
| K955856 | TEX-AID BLUE | Feb 16, 1996 | Substantially Equivalent |
| K955810 | U-TEX | Jan 24, 1996 | Substantially Equivalent |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Jul 6, 1995 | Substantially Equivalent |
| K942563 | ELITE BIOFEEDBACK | Jun 6, 1995 | Substantially Equivalent |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Jul 12, 1994 | Substantially Equivalent |
| K934369 | DRI SLEEPER | Nov 24, 1993 | Substantially Equivalent |
| K931574 | ADVANCE MODEL UDS-ADV | Aug 5, 1993 | Substantially Equivalent |
| K930005 | DRITRAINER | Mar 3, 1993 | Substantially Equivalent |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Oct 20, 1992 | Substantially Equivalent |