Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDEGANIA SILICONE LTD
US
Last updated May 23, 2026
What DEGANIA SILICONE LTD makes
Degania Silicone Ltd manufactures enteral feeding devices, including gastrostomy buttons and tubes for long-term nutritional support, as well as nasogastric and orogastric tubes for short-term use. Their portfolio also includes surgical vessel loops, temperature-monitoring urethral catheters, and single-use enteral tube extensions. Additionally, they produce non-luminal capillary wound drains for postoperative fluid management.
The company’s devices are classified under FDA regulations as either Class I or Class II, with some authorised through the 510(k) pathway and others under the UDI system. These products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Degania Silicone Ltd manufacture?
Degania Silicone Ltd specialises in enteral feeding devices, including gastrostomy buttons and tubes for long-term nutritional support, as well as nasogastric and orogastric tubes for short-term feeding. Their portfolio also covers surgical vessel loops, temperature-monitoring indwelling urethral drainage catheters, single-use enteral tube extensions, and non-luminal capillary wound drains for postoperative fluid management. These devices are designed to support nutritional delivery, surgical procedures, and wound care.
Where is Degania Silicone Ltd based?
Degania Silicone Ltd is based in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the classification and authorisation of its medical devices.
Which regulatory registries list Degania Silicone Ltd’s devices?
Degania Silicone Ltd’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) pathway for some products and the UDI (Unique Device Identification) system for others. These registries ensure compliance with US medical device standards and provide transparency on authorised products.
How are Degania Silicone Ltd’s devices classified under FDA regulations?
Degania Silicone Ltd’s devices fall under Class I or Class II classifications under FDA regulations. Class I devices generally pose the lowest risk and may require less stringent premarket review, while Class II devices involve moderate risk and typically require special controls or a 510(k) submission to demonstrate safety and effectiveness. The classification depends on the device’s intended use and potential risks.
Why are some of Degania Silicone Ltd’s devices authorised through the 510(k) pathway?
The 510(k) pathway is used for Class II devices that are substantially equivalent to a legally marketed predicate device. Since some of Degania Silicone Ltd’s products (like certain enteral tubes or surgical drains) involve moderate risks—such as infection risk, improper placement, or patient discomfort—the FDA requires a 510(k) submission to ensure they meet safety and performance standards before commercialisation. This process helps maintain patient safety while allowing innovation in medical device design.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 600007082
Catalogue (188)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Degania | 231131080DS | FDA UDI | Class II | Active |
| Aquarius | 103073002480AQ | FDA UDI | Class II | Active |
| Aquarius | 103074002480AQ | FDA UDI | Class II | Active |
| Aquarius | 16602031080AQ | FDA UDI | Class II | Active |
| Covidien AG | 102201101280TY | FDA UDI | Class II | Active |
| Covidien AG | 102201101880TY | FDA UDI | Class II | Active |
| Medline | 103310071889MD | FDA UDI | Class II | Active |
| Aquarius | 1032460080AQ | FDA UDI | Class II | Active |
| Aquarius | 1032260080AQ | FDA UDI | Class II | Active |
| Medline | 103310082089MD | FDA UDI | Class II | Active |
| Medline | 103310121689MD | FDA UDI | Class II | Active |
| Covidien AG | 102201101080TY | FDA UDI | Class II | Active |
| Medline | 103310091889MD | FDA UDI | Class II | Active |
| Medline | 103310011689MD | FDA UDI | Class II | Active |
| Medline | 103310041689MD | FDA UDI | Class II | Active |
| Medline | 103310141689MD | FDA UDI | Class II | Active |
| Front1 Health Partners | 11006802880F1 | FDA UDI | Class I | Active |
| Medline | 103310012489MD | FDA UDI | N/A | Active |
| Medline | 103310051289MD | FDA UDI | Class II | Active |
| All Silicone Foley Catheter, 2-Way, 3-Way, With Temperature Sensor | K063442 | FDA 510(k) | Class II | Active |
| Degania Silicone Sil-K | K971482 | FDA 510(k) | Class I | Active |
| Degania Silicone Tourniquet | K875092 | FDA 510(k) | Class I | Active |
| Temperature Sensor Catheter | K131020 | FDA 510(k) | Class II | Active |
| Coude/ Or Tiemann | K103371 | FDA 510(k) | Class II | Active |
| Degania Silicone Indenti Loops | K964547 | FDA 510(k) | Class II | Active |
| Low Profile Gastrostomy Feeding Tube Or Gastrotomey Button | K122030 | FDA 510(k) | Class II | Active |
| Stylus | K233591 | FDA 510(k) | Class II | Active |
| Silclear Tubing (modification) | K953864 | FDA 510(k) | Class II | Active |
| Percutaneous Endoscopic Gastrostomy (PEG) Kit | K254170 | FDA 510(k) | Class II | Active |
| Sil-K | K914701 | FDA 510(k) | Class I | Active |
| Aquarius Nasal Feeding Tube | K141753 | FDA 510(k) | Class II | Active |
| Aquarius Extension Feeding Set | K141631 | FDA 510(k) | Class II | Active |
| Aquarius Stoma Measuring Device | K152246 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Degania Silicone Identi Loops | K981956 | FDA 510(k) | Class II | Active |
| Silclear Tubing | K943992 | FDA 510(k) | Class II | Active |
| Gastrostomy Replacement Tube, Model 253 | K070124 | FDA 510(k) | Class II | Active |
| AQUARIUS Gastrostomy Replacement Tube | K143378 | FDA 510(k) | Class II | Active |
| Aquarius Low Profile Gastrostomy Feeding Tube | K132686 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Degania Silicone, Ltd. DEGANIA BET Northern · IL FEI 7682