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 |
|---|---|---|---|
| Dec 13, 2012 | K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE Neurovision Medical Products, Inc. | FAP |
| Feb 19, 1998 | K974775 | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE Airtronic Services, Inc. | FAP |
| Apr 3, 1997 | K963330 | URODYNAMIC ANALYSIS MODULE Synectics Medical, Inc., SE | FAP |
| Aug 27, 1996 | K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER Rusch Intl. | FAP |
| Apr 1, 1994 | K931175 | SCHUSTER DISPOSABLE BALLOON PROBE Sandhill Scientific, Inc. | FAP |
| Nov 18, 1993 | K931179 | UROLAB SPECTRUM Life-Tech Intl., Inc. | FAP |
| Jul 20, 1993 | K922476 | URO-PRO 2000 Fiberoptic Sensor Technlogies, Inc. | FAP |
| Jun 18, 1993 | K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO Synectics-Dantec | FAP |
| Apr 8, 1993 | K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 Advanced Medical Products, Inc. | FAP |
| Feb 5, 1993 | K923464 | URODYNAMIC CATHETERS R.L. Medical Corp. | FAP |
| Oct 20, 1992 | K924086 | NICKI, MODEL NUMBER USD-NK-UP1 Laborie Medical Technologies, Ltd. | FAP |
| Sep 17, 1992 | K920451 | ENDOTEK ULTRA SYSTEM Surgitek | FAP |
| Sep 4, 1992 | K920777 | LABORIE URODYNAMICS PROCESSOR R. Laborie Surgical , Ltd. | FAP |
| Jul 23, 1992 | K920575 | MERKUR 4000 F.M. Wiest USA, Inc. | FAP |
| Jun 2, 1992 | K914300 | PHOENIX 5 URODYNAMICS SYSTEM Aspen Medical , Ltd., GB | FAP |
| Apr 10, 1992 | K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM Browne Medical Systems, Inc. | FAP |
| Apr 10, 1992 | K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED Browne Medical Systems, Inc. | FAP |
| Apr 10, 1992 | K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION Browne Medical Systems, Inc. | FAP |
| Feb 24, 1992 | K915484 | URETHRALPRESSURE PROFILE CATHETER Life-Tech Intl., Inc. | FAP |
| Feb 19, 1992 | K915443 | URODYNAMIC CATHETER Cook Urological, Inc. | FAP |
| Feb 7, 1992 | K913736 | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST Biosearch Medical Products, Inc. | FAP |
| Jan 23, 1992 | K913169 | DANTEC UD 5500 MK2 Dantec Medical, Inc. | FAP |
| Jan 7, 1992 | K914891 | PULLER OPTION FOR ETUDE(TM) Dantec Medical, Inc. | FAP |
| Dec 9, 1991 | K912701 | DANTEC MENUET Dantec Medical, Inc. | FAP |
| Dec 2, 1991 | K912451 | URODYNAMIC RECTAL BALLOON Cook Urological, Inc. | FAP |
| Sep 23, 1991 | K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) Dantec Medical, Inc. | FAP |
| Aug 15, 1991 | K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 Diagnostic Ultrasound Corp. | FAP |
| Jun 10, 1991 | K911091 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES Diagnostic Ultrasound Corp. | FAP |
| Jun 10, 1991 | K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO Browne Medical Systems, Inc. | FAP |
| May 15, 1991 | K910371 | URODYNAMIC MEASURING SYSTEM Browne Medical Systems, Inc. | FAP |
| Apr 2, 1991 | K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP Browne Medical Systems, Inc. | FAP |
| Apr 2, 1991 | K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM Browne Medical Systems, Inc. | FAP |
| Mar 19, 1991 | K904646 | BCI-100 FECAL INCONTINENCE SYSTEM Biocare Intl. | FAP |
| Nov 27, 1990 | K904386 | UROLAB JANUS Life-Tech Intl., Inc. | FAP |
| Oct 26, 1990 | K901494 | ETUDE, URODYNAMIC INVESTIGATION SYSTEM Dantec Medical, Inc. | FAP |
| Sep 14, 1990 | K902843 | BIOSEARCH ANAL BIOFEEDBACK DEVICE Biosearch Medical Products, Inc. | FAP |
| Sep 13, 1990 | K902692 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 Diagnostic Ultrasound Corp. | FAP |
| Jun 11, 1990 | K900494 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM Synectics-Dantec | FAP |
| May 3, 1990 | K896575 | DANTEC MENUET Dantec Medical, Inc. | FAP |
| Dec 8, 1989 | K884920 | RECTUM-COLON MOTILITY MONITOR Multi-Spectrum Consulting, Inc. | FAP |
| Oct 4, 1989 | K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER Dantec Electronics, Inc. | FAP |
| Aug 11, 1988 | K881736 | SURGITEK CO2 DELIVERY SYSTEM Medical Engineering Corp. | FAP |
| Apr 14, 1988 | K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE Dantec Electronics, Inc. | FAP |
| Apr 14, 1988 | K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE Dantec Electronics, Inc. | FAP |
| Jun 9, 1987 | K870855 | UROSCAN Endotherapeutics | FAP |
| Dec 3, 1986 | K863312 | SANDHILL AMS Sandhill | FAP |
| Oct 28, 1986 | K863165 | MODEL 4-SC FOUR WAY STOPCOCK Life-Tech Intl., Inc. | FAP |
| Oct 24, 1986 | K863168 | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD Life-Tech Intl., Inc. | FAP |
| Oct 24, 1986 | K863167 | MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR Life-Tech Intl., Inc. | FAP |
| Sep 9, 1986 | K863169 | MODEL AS-72 ADMINISTRATION SET Life-Tech Intl., Inc. | FAP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.