FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICKI, MODEL NUMBER USD-NK-UP1
K Number: K924086
·
Decision Oct 20, 1992
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
11
Review Days
68
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Basic Information
- Device Name
- NICKI, MODEL NUMBER USD-NK-UP1
- K Number
- K924086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laborie Medical Technologies, Ltd.
- Date Received
- August 13, 1992
- Decision Date
- October 20, 1992
- Product Code
- FAP
- 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 |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAP), ordered by most recent decision date.
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
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SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
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URODYNAMIC ANALYSIS MODULE
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RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
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SCHUSTER DISPOSABLE BALLOON PROBE
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FDA Class 2
·Gastroenterology, Urology
UROLAB SPECTRUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |