Skip to content

510(k) K833790 · KOD Catheter, Urological

CURITY 100% SILICONE COUDE' CATHETER

Applicant	The Kendal Co., Mchenry IL, US
Decision	Substantially Equivalent, Dec 27, 1983
Received	Oct 31, 1983
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K833790

Date	Firm and product	Code	Linked 510(k)
Mar 21, 2016	Covidien LLC Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: PP14SD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed
Mar 21, 2016	Covidien LLC Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients Terminated	EZL	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.