FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
U-TEX
K Number: K955810
·
Decision Jan 24, 1996
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
10
Applicant Total
11
Review Days
29
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Basic Information
- Device Name
- U-TEX
- K Number
- K955810
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5160
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laborie Medical Technologies, Ltd.
- Date Received
- December 26, 1995
- Decision Date
- January 24, 1996
- Product Code
- FHA
- 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 |
|---|---|---|---|
| FHA | Clamp, Penile | FDA class 1 | 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 |
| K962009 | UROSTYM | May 20, 1997 | Substantially Equivalent |
| K955856 | TEX-AID BLUE | Feb 16, 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 |