FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
K Number: K850601
·
Decision Apr 25, 1985
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
68
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
- K Number
- K850601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- February 15, 1985
- Decision Date
- April 25, 1985
- 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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
URODYNAMIC ANALYSIS MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCHUSTER DISPOSABLE BALLOON PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent |
| K954505 | EZ STIM | 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 |