Degania Silicone, Ltd.
FDA Regulatory Profile
Degania Silicone, Ltd. appears in FDA public data with 43 recalls, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0809-2020, Class II) was initiated on December 2, 2019. Its most recent 510(k) clearance was granted on March 20, 2026.
Summary
- Total Recalls
- 43
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0809-2020 | Class II | Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medlin | December 2, 2019 |
| Z-2263-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An int | June 28, 2019 |
| Z-2267-2019 | Class II | Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introducti | June 28, 2019 |
| Z-2264-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP- | June 28, 2019 |
| Z-2260-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainag | June 28, 2019 |
| Z-2266-2019 | Class II | Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage cathet | June 28, 2019 |
| Z-2261-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An i | June 28, 2019 |
| Z-2262-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-21 | June 28, 2019 |
| Z-2265-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2 | June 28, 2019 |
| Z-2779-2018 | Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is ster | June 21, 2018 |
| Z-2765-2018 | Class II | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: | June 21, 2018 |
| Z-2754-2018 | Class II | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is s | June 21, 2018 |
| Z-2755-2018 | Class II | Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is st | June 21, 2018 |
| Z-2762-2018 | Class II | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile | June 21, 2018 |
| Z-2782-2018 | Class II | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is steril | June 21, 2018 |
| Z-2759-2018 | Class II | Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile | June 21, 2018 |
| Z-2780-2018 | Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is st | June 21, 2018 |
| Z-2758-2018 | Class II | Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile | June 21, 2018 |
| Z-2766-2018 | Class II | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: | June 21, 2018 |
| Z-2772-2018 | Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Produc | June 21, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | March 20, 2026 |
| K233591 | Stylus | May 31, 2024 |
| K152246 | Aquarius Stoma Measuring Device | June 21, 2016 |
| K143378 | AQUARIUS Gastrostomy Replacement Tube | December 29, 2014 |
| K141753 | AQUARIUS NASAL FEEDING TUBE | October 16, 2014 |
| K141631 | AQUARIUS EXTENSION FEEDING SET | July 28, 2014 |
| K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE | May 12, 2014 |
| K131020 | TEMPERATURE SENSOR CATHETER | May 9, 2013 |
| K122030 | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON | September 5, 2012 |
| K103371 | COUDE/ OR TIEMANN | March 11, 2011 |
| K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 | May 23, 2007 |
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | March 26, 2007 |
| K981956 | DEGANIA SILICONE IDENTI LOOPS | July 9, 1998 |
| K971482 | DEGANIA SILICONE SIL-K | June 24, 1997 |
| K964547 | DEGANIA SILICONE INDENTI LOOPS | January 8, 1997 |
| K953864 | SILCLEAR TUBING (MODIFICATION) | November 6, 1995 |
| K943992 | SILCLEAR TUBING | March 16, 1995 |
| K914701 | SIL-K | January 31, 1992 |
| K875092 | DEGANIA SILICONE TOURNIQUET | January 7, 1988 |