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FAP — Cystometric Gas (Carbon-Dioxide) On Hydraulic Device Class II

FDA Device Classification

Classification Details

Product Code
FAP
Device Class
Class II
Regulation Number
876.1620
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K113771neurovision medical productsSIGNAL GEAR URETHRAL CATHETER ELECTRODEDecember 13, 2012
K974775airtronic servicesSINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEFebruary 19, 1998
K963330synectics medicalURODYNAMIC ANALYSIS MODULEApril 3, 1997
K962472rusch intlRUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERAugust 27, 1996
K931175sandhill scientificSCHUSTER DISPOSABLE BALLOON PROBEApril 1, 1994
K931179life-tech intlUROLAB SPECTRUMNovember 18, 1993
K922476fiberoptic sensor technlogiesURO-PRO 2000July 20, 1993
K924383synectics-dantecSYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM UROJune 18, 1993
K923995advanced medical productsURODYNAMICS TUBING KITS #5161, #5150, #7170April 8, 1993
K923464r.l. medicalURODYNAMIC CATHETERSFebruary 5, 1993
K924086laborie medical technologiesNICKI, MODEL NUMBER USD-NK-UP1October 20, 1992
K920451surgitekENDOTEK ULTRA SYSTEMSeptember 17, 1992
K920777r. laborie surgicalLABORIE URODYNAMICS PROCESSORSeptember 4, 1992
K920575f.m. wiest usaMERKUR 4000July 23, 1992
K914300aspen medicalPHOENIX 5 URODYNAMICS SYSTEMJune 2, 1992
K921047browne medical systemsMODEL 8100 URODYNAMICS MEASURING SYSTEMApril 10, 1992
K920992browne medical systemsPROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIEDApril 10, 1992
K920991browne medical systemsIMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATIONApril 10, 1992
K915484life-tech intlURETHRALPRESSURE PROFILE CATHETERFebruary 24, 1992
K915443cook urologicalURODYNAMIC CATHETERFebruary 19, 1992