FDA Product Code
FDA Product Code FAP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1620
510(k) Clearances — 85 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Neurovision Medical Products, Inc. | 2012-12-13 | Traditional | PDF ↗ |
| K974775 | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE | Airtronic Services, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K963330 | URODYNAMIC ANALYSIS MODULE | Synectics Medical, Inc. | 1997-04-03 | Traditional | PDF ↗ |
| K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | Rusch Intl. | 1996-08-27 | Traditional | PDF ↗ |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | Sandhill Scientific, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | 1993-11-18 | Traditional | PDF ↗ |
| K922476 | URO-PRO 2000 | Fiberoptic Sensor Technlogies, Inc. | 1993-07-20 | Traditional | PDF ↗ |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Synectics-Dantec | 1993-06-18 | Traditional | PDF ↗ |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | Advanced Medical Products, Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K923464 | URODYNAMIC CATHETERS | R.L. Medical Corp. | 1993-02-05 | Traditional | PDF ↗ |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | 1992-10-20 | Traditional | PDF ↗ |
| K920451 | ENDOTEK ULTRA SYSTEM | Surgitek | 1992-09-17 | Traditional | PDF ↗ |
| K920777 | LABORIE URODYNAMICS PROCESSOR | R. Laborie Surgical , Ltd. | 1992-09-04 | Traditional | PDF ↗ |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | 1992-07-23 | Traditional | PDF ↗ |
| K914300 | PHOENIX 5 URODYNAMICS SYSTEM | Aspen Medical , Ltd. | 1992-06-02 | Traditional | PDF ↗ |
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | Browne Medical Systems, Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Browne Medical Systems, Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Browne Medical Systems, Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K915484 | URETHRALPRESSURE PROFILE CATHETER | Life-Tech Intl., Inc. | 1992-02-24 | Traditional | PDF ↗ |
| K915443 | URODYNAMIC CATHETER | Cook Urological, Inc. | 1992-02-19 | Traditional | PDF ↗ |
| K913736 | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST | Biosearch Medical Products, Inc. | 1992-02-07 | Traditional | PDF ↗ |
| K913169 | DANTEC UD 5500 MK2 | Dantec Medical, Inc. | 1992-01-23 | Traditional | PDF ↗ |
| K914891 | PULLER OPTION FOR ETUDE(TM) | Dantec Medical, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K912701 | DANTEC MENUET | Dantec Medical, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K912451 | URODYNAMIC RECTAL BALLOON | Cook Urological, Inc. | 1991-12-02 | Traditional | PDF ↗ |
| K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) | Dantec Medical, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 | Diagnostic Ultrasound Corp. | 1991-08-15 | Traditional | PDF ↗ |
| K911091 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES | Diagnostic Ultrasound Corp. | 1991-06-10 | Traditional | PDF ↗ |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | Browne Medical Systems, Inc. | 1991-06-10 | Traditional | PDF ↗ |
| K910371 | URODYNAMIC MEASURING SYSTEM | Browne Medical Systems, Inc. | 1991-05-15 | Traditional | PDF ↗ |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | Browne Medical Systems, Inc. | 1991-04-02 | Traditional | PDF ↗ |
| K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP | Browne Medical Systems, Inc. | 1991-04-02 | Traditional | PDF ↗ |
| K904646 | BCI-100 FECAL INCONTINENCE SYSTEM | Biocare Intl. | 1991-03-19 | Traditional | PDF ↗ |
| K904386 | UROLAB JANUS | Life-Tech Intl., Inc. | 1990-11-27 | Traditional | PDF ↗ |
| K901494 | ETUDE, URODYNAMIC INVESTIGATION SYSTEM | Dantec Medical, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K902843 | BIOSEARCH ANAL BIOFEEDBACK DEVICE | Biosearch Medical Products, Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K902692 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 | Diagnostic Ultrasound Corp. | 1990-09-13 | Traditional | PDF ↗ |
| K900494 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM | Synectics-Dantec | 1990-06-11 | Traditional | PDF ↗ |
| K896575 | DANTEC MENUET | Dantec Medical, Inc. | 1990-05-03 | Traditional | PDF ↗ |
| K884920 | RECTUM-COLON MOTILITY MONITOR | Multi-Spectrum Consulting, Inc. | 1989-12-08 | Traditional | PDF ↗ |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | Dantec Electronics, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Medical Engineering Corp. | 1988-08-11 | Traditional | PDF ↗ |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | Dantec Electronics, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | Dantec Electronics, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K870855 | UROSCAN | Endotherapeutics | 1987-06-09 | Traditional | PDF ↗ |
| K863312 | SANDHILL AMS | Sandhill | 1986-12-03 | Traditional | PDF ↗ |
| K863165 | MODEL 4-SC FOUR WAY STOPCOCK | Life-Tech Intl., Inc. | 1986-10-28 | Traditional | PDF ↗ |
| K863167 | MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR | Life-Tech Intl., Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K863168 | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD | Life-Tech Intl., Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K863169 | MODEL AS-72 ADMINISTRATION SET | Life-Tech Intl., Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K862327 | MODEL RCV REFLUX CHECK VALVE | Life-Tech Intl., Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K860571 | F.M. WEIST,KG (URODYNAMIC SYSTEMS) | F.M. Wiest USA, Inc. | 1986-03-18 | Traditional | PDF ↗ |
| K853683 | UMS-100 | Narco Bio-Systems | 1986-01-10 | Traditional | PDF ↗ |
| K853059 | LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE | Tridak Division of Indicon, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K853936 | 1351 UROFLOW AUTO START | Life-Tech Intl., Inc. | 1985-12-02 | Traditional | PDF ↗ |
| K852856 | LABORIE URODYNAMICS PROCESSOR | Tridak Division of Indicon, Inc. | 1985-10-17 | Traditional | PDF ↗ |
| K851483 | UROBEI STRESS INCONTINENCE MONITOR | Browne Medical, Inc. | 1985-08-07 | Traditional | PDF ↗ |
| K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC | Warne Surgical Products, Ltd. | 1985-05-17 | Traditional | PDF ↗ |
| K850694 | WSP CODE 4310 STRESSCATH | Warne Surgical Products, Ltd. | 1985-05-17 | Traditional | PDF ↗ |
| K850695 | WSP CODE 4301 DIOMASTER THERAPEUTIC | Warne Surgical Products, Ltd. | 1985-05-16 | Traditional | PDF ↗ |
| K850693 | WSP CODE 4315 PADTEST | Warne Surgical Products, Ltd. | 1985-05-10 | Traditional | PDF ↗ |
| K850601 | MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR | Life-Tech Intl., Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850602 | 1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE | Life-Tech Intl., Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK | Epcom Medical Systems, Inc. | 1985-01-02 | Traditional | PDF ↗ |
| K842124 | EMG MODULE, EMG1, W/OPTIONAL SPEAKER | Endotek Corp. | 1984-08-08 | Traditional | PDF ↗ |
| K834503 | PROFILE URODYNAMIC MONITORING SYS | Browne Medical, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K833628 | LUMEN-4 URODYNAMIC CATHETER | Surgitek | 1983-11-28 | Traditional | PDF ↗ |
| K823561 | URETHRAL PRESSURE PROFILE & TEMP. MODUL | Nihon Kohden America, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K822916 | UROCOMP REMOTE CONTROL 1804 | Life-Tech Intl., Inc. | 1982-12-13 | Traditional | PDF ↗ |
| K823432 | 1512M/F WIRE ELECTRODE NEEDLE SET | Life-Tech Intl., Inc. | 1982-11-30 | Traditional | PDF ↗ |
| K821939 | UROCOMP MODEL 1404 | Life-Tech Intl., Inc. | 1982-07-13 | Traditional | PDF ↗ |
| K820144 | DISA WATER CYSTOMETER | Disa Electronics | 1982-03-23 | Traditional | PDF ↗ |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | Life-Tech Instruments, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K802374 | ROBERTSON OBTURATION MONITOR INSUFFLA | Endotek Corp. | 1980-11-24 | Traditional | PDF ↗ |
| K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE | Kli | 1980-06-17 | Traditional | PDF ↗ |
| K792090 | BROWNE MODEL UD-4 | Browne Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K792092 | BROWNE MODEL UD-4E | Browne Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K792094 | BROWNE MODEL UA-6 | Browne Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K792091 | BROWNE MODEL UD-4D | Browne Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K792093 | BROWNE MODEL GD-5 | Browne Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K790478 | BROWNE MODEL UD-4DE | Browne Corp. | 1979-06-01 | Traditional | PDF ↗ |
| K790754 | BROWNE MODEL CF-1 AND CF-1G | Browne Corp. | 1979-06-01 | Traditional | PDF ↗ |
| K790519 | ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 | American Medical Systems, Inc. | 1979-05-14 | Traditional | PDF ↗ |
| K771850 | UROFLOW-CYSTOMETER SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-10-18 | Traditional | PDF ↗ |
| K770579 | CATHETER, URETHRAL PRESSURE, UPE-10 & 12 | Life-Tech Instruments, Inc. | 1977-05-23 | Traditional | PDF ↗ |
Product code FAP · Class II · Gastroenterology, Urology. Data: openFDA.