Company ยท IL
Degania Silicone, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
43recalls (0 in 12 months)
33recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 36 |
| GBX | Catheter, Irrigation | 10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 7 |
| DXC | Clamp, Vascular | 2 |
| FPK | Tubing, Fluid Delivery | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 |
| GAX | Tourniquet, Nonpneumatic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2026 | K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit Degania Silicone , Ltd., IL | PIF |
| May 31, 2024 | K233591 | Stylus Degania Silicone , Ltd., IL | KNT |
| Jun 21, 2016 | K152246 | Aquarius Stoma Measuring Device Degania Silicone , Ltd., IL | KNT |
| Dec 29, 2014 | K143378 | AQUARIUS Gastrostomy Replacement Tube Degania Silicone , Ltd., IL | KNT |
| Oct 16, 2014 | K141753 | AQUARIUS NASAL FEEDING TUBE Degania Silicone , Ltd., IL | PIF |
| Jul 28, 2014 | K141631 | AQUARIUS EXTENSION FEEDING SET Degania Silicone , Ltd., IL | KNT |
| May 12, 2014 | K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE Degania Silicone , Ltd., IL | KNT |
| May 9, 2013 | K131020 | TEMPERATURE SENSOR CATHETER Degania Silicone , Ltd., IL | EZL |
| Sep 5, 2012 | K122030 | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON Degania Silicone , Ltd., IL | KNT |
| Mar 11, 2011 | K103371 | COUDE/ OR TIEMANN Degania Silicone , Ltd., IL | EZL |
| May 23, 2007 | K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 Degania Silicone , Ltd., IL | KNT |
| Mar 26, 2007 | K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR Degania Silicone , Ltd., IL | EZL |
| Jul 9, 1998 | K981956 | DEGANIA SILICONE IDENTI LOOPS Degania Silicone , Ltd., IL | DXC |
| Jun 24, 1997 | K971482 | DEGANIA SILICONE SIL-K Degania Silicone , Ltd., IL | MDA |
| Jan 8, 1997 | K964547 | DEGANIA SILICONE INDENTI LOOPS Degania Silicone , Ltd., IL | DXC |
| Nov 6, 1995 | K953864 | SILCLEAR TUBING (MODIFICATION) Degania Silicone , Ltd., IL | FPK |
| Mar 16, 1995 | K943992 | SILCLEAR TUBING Degania Silicone , Ltd., IL | FPK |
| Jan 31, 1992 | K914701 | SIL-K Degania Silicone , Ltd., IL | MDA |
| Jan 7, 1988 | K875092 | DEGANIA SILICONE TOURNIQUET Degania Silicone , Ltd., IL | GAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2019 | Degania Silicone, Ltd. Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile
Catalog Number: 102201101463MD {Medline code 55346)
Monitor urinary output and bladder temperature in addition to facilitating urine drain Terminated |
EZL | K063442 |
| Jun 28, 2019 | Degania Silicone, Ltd. Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain
PN: 02872
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to in Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Medline Silicone Drain 15Fr 3/16" Full Fluted
PN: DYNJWE2188HB
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fl Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar
Cardinal Health: PN JP-2225
An introduction/drainage catheter is a device that is a flexible single or multilumen tube inten Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar
Cardinal Health: PN: JP-2191
An introduction/drainage catheter is a device that is a flexible single or multilumen tube inte Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes
Cardinal Health: PN JP-2190
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be use Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar
Product Number: JP-2189
An introduction/drainage catheter is a device that is a flexible single or multilumen tube inten Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes
Cardinal Health PN: JP-2188
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be u Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 15FR
Cardinal PN:JP-2223
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce no Terminated |
GBX | None listed |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensing catheter 16FR, Catalogue Number 102201101663NU
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensing catheter 14FR, Catalogue Number 102201101463NU
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensing catheter 18FR, Catalogue Number 102203101863DO
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensing catheter 16FR, Catalogue Number 102203101663DO
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensing catheter 14FR, Catalogue Number 102203101463DO
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is int Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in th Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third l Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inte Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is inten Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is Terminated |
EZL | K063442 |
| Jun 21, 2018 | Degania Silicone, Ltd. Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB
Product Usage:
This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It i Terminated |
EZL | K063442 |
| Feb 20, 2018 | Degania Silicone, Ltd. Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234.
Used for the drainage of body fluids for surgical use. Terminated |
GBX | None listed |
| Feb 22, 2017 | Degania Silicone, Ltd. Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx
Distributed by Cardinal Health, USA
Catalog Number: JP-2187
For wound drainage. Terminated |
GBX | None listed |