FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETHRALPRESSURE PROFILE CATHETER
K Number: K915484
·
Decision Feb 24, 1992
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
68
Review Days
80
Basic Information
- Device Name
- URETHRALPRESSURE PROFILE CATHETER
- K Number
- K915484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LIFE-TECH INTL., INC.
- Date Received
- December 6, 1991
- Decision Date
- February 24, 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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SCHUSTER DISPOSABLE BALLOON PROBE
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UROLAB SPECTRUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by LIFE-TECH INTL., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K001129 | PROLONG, MODELS PL50, PL100, PL150 | Jul 6, 2000 | Substantially Equivalent |
| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent |
| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |