Atlas FDA

FAP

85 FDA 510(k) clearances · Product code

78 daysmedian time to decision
241 days90th percentile
85clearances measured

FDA profile

Official device name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1620
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
1999: 2 · 2000: 1 · 2001: 3 · 2025: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SIGNAL GEAR URETHRAL CATHETER ELECTRODE (K113771)Neurovision Medical Products, Inc.2012-12-13
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (K974775)Airtronic Services, Inc.1998-02-19
URODYNAMIC ANALYSIS MODULE (K963330)Synectics Medical, Inc.1997-04-03
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (K962472)Rusch Intl.1996-08-27
SCHUSTER DISPOSABLE BALLOON PROBE (K931175)Sandhill Scientific, Inc.1994-04-01
UROLAB SPECTRUM (K931179)Life-Tech Intl., Inc.1993-11-18
URO-PRO 2000 (K922476)Fiberoptic Sensor Technlogies, Inc.1993-07-20
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (K924383)Synectics-Dantec1993-06-18
URODYNAMICS TUBING KITS #5161, #5150, #7170 (K923995)Advanced Medical Products, Inc.1993-04-08
URODYNAMIC CATHETERS (K923464)R.L. Medical Corp.1993-02-05
NICKI, MODEL NUMBER USD-NK-UP1 (K924086)Laborie Medical Technologies, Ltd.1992-10-20
ENDOTEK ULTRA SYSTEM (K920451)Surgitek1992-09-17
LABORIE URODYNAMICS PROCESSOR (K920777)R. Laborie Surgical , Ltd.1992-09-04
MERKUR 4000 (K920575)F.M. Wiest USA, Inc.1992-07-23
PHOENIX 5 URODYNAMICS SYSTEM (K914300)Aspen Medical , Ltd.1992-06-02
PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED (K920992)Browne Medical Systems, Inc.1992-04-10
IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION (K920991)Browne Medical Systems, Inc.1992-04-10
MODEL 8100 URODYNAMICS MEASURING SYSTEM (K921047)Browne Medical Systems, Inc.1992-04-10
URETHRALPRESSURE PROFILE CATHETER (K915484)Life-Tech Intl., Inc.1992-02-24
URODYNAMIC CATHETER (K915443)Cook Urological, Inc.1992-02-19
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST (K913736)Biosearch Medical Products, Inc.1992-02-07
DANTEC UD 5500 MK2 (K913169)Dantec Medical, Inc.1992-01-23
PULLER OPTION FOR ETUDE(TM) (K914891)Dantec Medical, Inc.1992-01-07
DANTEC MENUET (K912701)Dantec Medical, Inc.1991-12-09
URODYNAMIC RECTAL BALLOON (K912451)Cook Urological, Inc.1991-12-02
ETUDE (MODEL NUMBERS 24A05 & 24A06) (K913323)Dantec Medical, Inc.1991-09-23
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 (K911125)Diagnostic Ultrasound Corp.1991-08-15
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES (K911091)Diagnostic Ultrasound Corp.1991-06-10
BROWNE MEDICAL SYSTEMS IMAGEPRO (K910444)Browne Medical Systems, Inc.1991-06-10
URODYNAMIC MEASURING SYSTEM (K910371)Browne Medical Systems, Inc.1991-05-15
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM (K910217)Browne Medical Systems, Inc.1991-04-02
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP (K910285)Browne Medical Systems, Inc.1991-04-02
BCI-100 FECAL INCONTINENCE SYSTEM (K904646)Biocare Intl.1991-03-19
UROLAB JANUS (K904386)Life-Tech Intl., Inc.1990-11-27
ETUDE, URODYNAMIC INVESTIGATION SYSTEM (K901494)Dantec Medical, Inc.1990-10-26
BIOSEARCH ANAL BIOFEEDBACK DEVICE (K902843)Biosearch Medical Products, Inc.1990-09-14
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 (K902692)Diagnostic Ultrasound Corp.1990-09-13
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM (K900494)Synectics-Dantec1990-06-11
DANTEC MENUET (K896575)Dantec Medical, Inc.1990-05-03
RECTUM-COLON MOTILITY MONITOR (K884920)Multi-Spectrum Consulting, Inc.1989-12-08
DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER (K884915)Dantec Electronics, Inc.1989-10-04
SURGITEK CO2 DELIVERY SYSTEM (K881736)Medical Engineering Corp.1988-08-11
DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE (K874758)Dantec Electronics, Inc.1988-04-14
13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE (K874759)Dantec Electronics, Inc.1988-04-14
UROSCAN (K870855)Endotherapeutics1987-06-09
SANDHILL AMS (K863312)Sandhill1986-12-03
MODEL 4-SC FOUR WAY STOPCOCK (K863165)Life-Tech Intl., Inc.1986-10-28
MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR (K863167)Life-Tech Intl., Inc.1986-10-24
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD (K863168)Life-Tech Intl., Inc.1986-10-24
MODEL AS-72 ADMINISTRATION SET (K863169)Life-Tech Intl., Inc.1986-09-09
MODEL RCV REFLUX CHECK VALVE (K862327)Life-Tech Intl., Inc.1986-09-04
F.M. WEIST,KG (URODYNAMIC SYSTEMS) (K860571)F.M. Wiest USA, Inc.1986-03-18
LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE (K853059)Tridak Division of Indicon, Inc.1986-01-10
UMS-100 (K853683)Narco Bio-Systems1986-01-10
1351 UROFLOW AUTO START (K853936)Life-Tech Intl., Inc.1985-12-02
LABORIE URODYNAMICS PROCESSOR (K852856)Tridak Division of Indicon, Inc.1985-10-17
UROBEI STRESS INCONTINENCE MONITOR (K851483)Browne Medical, Inc.1985-08-07
WSP CODE 4310 STRESSCATH (K850694)Warne Surgical Products, Ltd.1985-05-17
WSP CODE 4300 DIOMASTER DIAGNOSTIC (K850696)Warne Surgical Products, Ltd.1985-05-17
WSP CODE 4301 DIOMASTER THERAPEUTIC (K850695)Warne Surgical Products, Ltd.1985-05-16
WSP CODE 4315 PADTEST (K850693)Warne Surgical Products, Ltd.1985-05-10
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE (K850602)Life-Tech Intl., Inc.1985-04-25
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR (K850601)Life-Tech Intl., Inc.1985-04-25
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (K844503)Epcom Medical Systems, Inc.1985-01-02
EMG MODULE, EMG1, W/OPTIONAL SPEAKER (K842124)Endotek Corp.1984-08-08
PROFILE URODYNAMIC MONITORING SYS (K834503)Browne Medical, Inc.1984-02-21
LUMEN-4 URODYNAMIC CATHETER (K833628)Surgitek1983-11-28
URETHRAL PRESSURE PROFILE & TEMP. MODUL (K823561)Nihon Kohden America, Inc.1983-01-07
UROCOMP REMOTE CONTROL 1804 (K822916)Life-Tech Intl., Inc.1982-12-13
1512M/F WIRE ELECTRODE NEEDLE SET (K823432)Life-Tech Intl., Inc.1982-11-30
UROCOMP MODEL 1404 (K821939)Life-Tech Intl., Inc.1982-07-13
DISA WATER CYSTOMETER (K820144)Disa Electronics1982-03-23
LIFE-TECH #'S 1106/1156 UROLABS (K812178)Life-Tech Instruments, Inc.1981-08-13
ROBERTSON OBTURATION MONITOR INSUFFLA (K802374)Endotek Corp.1980-11-24
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE (K800822)Kli1980-06-17
BROWNE MODEL UA-6 (K792094)Browne Corp.1979-12-06
BROWNE MODEL GD-5 (K792093)Browne Corp.1979-12-06
BROWNE MODEL UD-4D (K792091)Browne Corp.1979-12-06
BROWNE MODEL UD-4E (K792092)Browne Corp.1979-12-06
BROWNE MODEL UD-4 (K792090)Browne Corp.1979-12-06
BROWNE MODEL UD-4DE (K790478)Browne Corp.1979-06-01
BROWNE MODEL CF-1 AND CF-1G (K790754)Browne Corp.1979-06-01
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 (K790519)American Medical Systems, Inc.1979-05-14
UROFLOW-CYSTOMETER SYSTEM (K771850)Richard Wolf Medical Instruments Corp.1977-10-18
CATHETER, URETHRAL PRESSURE, UPE-10 & 12 (K770579)Life-Tech Instruments, Inc.1977-05-23

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Every clearance here is in the API, with alerts when new ones post.