Atlas FDA

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

FDA 510(k) clearance K063442 · decided 2007-03-26

Clearance details

K-number
K063442
Device name
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
Applicant
Degania Silicone , Ltd.
Decision
Substantially Equivalent
Date received
2006-11-14
Decision date
2007-03-26
Days to decision
132 days
Clearance type
Traditional
Product code
EZL
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Emek Hayarden, IL
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Degania Silicone

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Rusch Latex Gold Foley Catheter (K262056)Teleflex Medical Sdn. Bhd.2026-08-05
Rusch SoftSimplastic Foley Catheters (K252537)Teleflex Medical Sdn. Bhd.2026-01-20
Silicone Urethral Catheter (Silicone Urethral Catheter) (K243011)Guangdong Ecan Medical Co., Ltd.2025-06-16
InnoCare Specialty Foley Catheter (K241424)Innocare Urologics, LLC2024-09-18
Rüsch Latex Gold Foley Catheter (K232469)Teleflexmedical, Inc.2024-08-01
TraumaGuard Intra-abdominal Pressure Sensing System (K240057)Sentinel Medical Technologies, LLC2024-04-17
Folysil Silicone Catheter (K233411)Coloplast Corp.2024-04-15
2-Way 100% Silicone Cleartract Catheter (K233013)Silq Technologies Corporation2024-01-23
Teleflex Rusch SoftSimplastic Foley Catheters (K212077)Teleflexmedical, Inc.2023-07-27
Flume Catheter (K231101)Flume Catheter Company, Ltd.2023-06-29
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (K221020)Potrero Medical, Inc.2023-01-13
2-Way 100% Silicone Cleartract Catheter (K222118)Silq Technologies, Corp.2022-12-01

Recalls involving this device

RecordFirmDate
Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are use recall (Z-1203-2016)Covidien LLC2016-03-21
Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes recall (Z-1205-2016)Covidien LLC2016-03-21
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 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes recall (Z-1208-2016)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 TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes recall (Z-1210-2016)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 UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes recall (Z-1213-2016)Covidien LLC2016-03-21
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap t recall (Z-1214-2016)Covidien LLC2016-03-21
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes recall (Z-1215-2016)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 PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap to recall (Z-1222-2016)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