Panels › Gastroenterology, Urology › Product code FAP · Class 2
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation 876.1620
0510(k)s in 12 months (85 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in FAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Life-Tech Intl., Inc. | 14 | 0 |
| Browne Corp. | 7 | 0 |
| Browne Medical Systems, Inc. | 7 | 0 |
| Dantec Medical, Inc. | 6 | 0 |
| Sandhill Scientific, Inc. | 1 | 3 |
| Warne Surgical Products, Ltd. | 4 | 0 |
| Dantec Electronics, Inc. | 3 | 0 |
| Diagnostic Ultrasound Corp. | 3 | 0 |
| Biosearch Medical Products, Inc. | 2 | 0 |
| Browne Medical, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 1986 | K862327 | MODEL RCV REFLUX CHECK VALVE Life-Tech Intl., Inc. | FAP |
| Mar 18, 1986 | K860571 | F.M. WEIST,KG (URODYNAMIC SYSTEMS) F.M. Wiest USA, Inc. | FAP |
| Jan 10, 1986 | K853683 | UMS-100 Narco Bio-Systems | FAP |
| Jan 10, 1986 | K853059 | LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE Tridak Division of Indicon, Inc. | FAP |
| Dec 2, 1985 | K853936 | 1351 UROFLOW AUTO START Life-Tech Intl., Inc. | FAP |
| Oct 17, 1985 | K852856 | LABORIE URODYNAMICS PROCESSOR Tridak Division of Indicon, Inc. | FAP |
| Aug 7, 1985 | K851483 | UROBEI STRESS INCONTINENCE MONITOR Browne Medical, Inc. | FAP |
| May 17, 1985 | K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC Warne Surgical Products, Ltd., IE | FAP |
| May 17, 1985 | K850694 | WSP CODE 4310 STRESSCATH Warne Surgical Products, Ltd., IE | FAP |
| May 16, 1985 | K850695 | WSP CODE 4301 DIOMASTER THERAPEUTIC Warne Surgical Products, Ltd., IE | FAP |
| May 10, 1985 | K850693 | WSP CODE 4315 PADTEST Warne Surgical Products, Ltd., IE | FAP |
| Apr 25, 1985 | K850602 | 1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE Life-Tech Intl., Inc. | FAP |
| Apr 25, 1985 | K850601 | MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR Life-Tech Intl., Inc. | FAP |
| Jan 2, 1985 | K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK Epcom Medical Systems, Inc. | FAP |
| Aug 8, 1984 | K842124 | EMG MODULE, EMG1, W/OPTIONAL SPEAKER Endotek Corp. | FAP |
| Feb 21, 1984 | K834503 | PROFILE URODYNAMIC MONITORING SYS Browne Medical, Inc. | FAP |
| Nov 28, 1983 | K833628 | LUMEN-4 URODYNAMIC CATHETER Surgitek | FAP |
| Jan 7, 1983 | K823561 | URETHRAL PRESSURE PROFILE & TEMP. MODUL Nihon Kohden America, Inc. | FAP |
| Dec 13, 1982 | K822916 | UROCOMP REMOTE CONTROL 1804 Life-Tech Intl., Inc. | FAP |
| Nov 30, 1982 | K823432 | 1512M/F WIRE ELECTRODE NEEDLE SET Life-Tech Intl., Inc. | FAP |
| Jul 13, 1982 | K821939 | UROCOMP MODEL 1404 Life-Tech Intl., Inc. | FAP |
| Mar 23, 1982 | K820144 | DISA WATER CYSTOMETER Disa Electronics | FAP |
| Aug 13, 1981 | K812178 | LIFE-TECH #'S 1106/1156 UROLABS Life-Tech Instruments, Inc. | FAP |
| Nov 24, 1980 | K802374 | ROBERTSON OBTURATION MONITOR INSUFFLA Endotek Corp. | FAP |
| Jun 17, 1980 | K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE Kli | FAP |
| Dec 6, 1979 | K792094 | BROWNE MODEL UA-6 Browne Corp. | FAP |
| Dec 6, 1979 | K792093 | BROWNE MODEL GD-5 Browne Corp. | FAP |
| Dec 6, 1979 | K792092 | BROWNE MODEL UD-4E Browne Corp. | FAP |
| Dec 6, 1979 | K792091 | BROWNE MODEL UD-4D Browne Corp. | FAP |
| Dec 6, 1979 | K792090 | BROWNE MODEL UD-4 Browne Corp. | FAP |
| Jun 1, 1979 | K790754 | BROWNE MODEL CF-1 AND CF-1G Browne Corp. | FAP |
| Jun 1, 1979 | K790478 | BROWNE MODEL UD-4DE Browne Corp. | FAP |
| May 14, 1979 | K790519 | ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 American Medical Systems, Inc. | FAP |
| Oct 18, 1977 | K771850 | UROFLOW-CYSTOMETER SYSTEM Richard Wolf Medical Instruments Corp. | FAP |
| May 23, 1977 | K770579 | CATHETER, URETHRAL PRESSURE, UPE-10 & 12 Life-Tech Instruments, Inc. | FAP |
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