Atlas FDA

CURITY 100% SILICONE COUDE' CATHETER

FDA 510(k) clearance K833790 · decided 1983-12-27

Clearance details

K-number
K833790
Device name
CURITY 100% SILICONE COUDE' CATHETER
Applicant
The Kendal Co.
Decision
Substantially Equivalent
Date received
1983-10-31
Decision date
1983-12-27
Days to decision
57 days
Clearance type
Traditional
Product code
KOD
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are recall (Z-1206-2016)Covidien LLC2016-03-21
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are u recall (Z-1209-2016)Covidien LLC2016-03-21
Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes a recall (Z-1211-2016)Covidien LLC2016-03-21
Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are recall (Z-1212-2016)Covidien LLC2016-03-21
Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are u recall (Z-1216-2016)Covidien LLC2016-03-21
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes recall (Z-1217-2016)Covidien LLC2016-03-21
Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP PRE-C recall (Z-1218-2016)Covidien LLC2016-03-21
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: P4P18XSD Castile soap towelettes are recall (Z-1219-2016)Covidien LLC2016-03-21
Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: PP14SD Castile soap towelettes are use recall (Z-1220-2016)Covidien LLC2016-03-21
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD Castile soap towelettes are recall (Z-1221-2016)Covidien LLC2016-03-21
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are use recall (Z-1223-2016)Covidien LLC2016-03-21
Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes a recall (Z-1224-2016)Covidien LLC2016-03-21
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are recall (Z-1225-2016)Covidien LLC2016-03-21
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap to recall (Z-1226-2016)Covidien LLC2016-03-21
Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are use recall (Z-1227-2016)Covidien LLC2016-03-21
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes a recall (Z-1228-2016)Covidien LLC2016-03-21
Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are recall (Z-1229-2016)Covidien LLC2016-03-21