Product Code: FAP FDA class 2 21 CFR 876.1620

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Gastroenterology, Urology

The Cystometric Gas (Carbon-Dioxide) or Hydraulic Device (product code FAP) is a urodynamic instrument that uses carbon dioxide gas or fluid to evaluate bladder pressure, volume, and compliance during cystometry. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.1620 in the Gastroenterology and Urology specialty. No special flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FAP
Device Class: FDA class 2
Regulation Number: 876.1620
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 85 510(k) clearances via K numbers.

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