Identifiers
- 510(k) Number
- K943992 FDA 510(k)
- FDA Product Code
- FPK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Silclear Tubing is a fluid delivery device manufactured by Degania Silicone Ltd. It is a transparent silicone tubing with color coded stripes, designed for medical and biotech industry applications.
The device is supplied in various packaging options including bulk, double packed, spooled and cut-to-length configurations. It is manufactured in Class 8 clean rooms in compliance with ISO 13485 quality standards. The device has FDA 510(k) clearance with product code FPK and is classified as Class II.
Frequently asked questions
What is Silclear Tubing used for?
Silclear Tubing is a fluid delivery device designed for medical and biotech industry applications. It is a transparent silicone tubing with color coded stripes that helps with identification and proper usage in various medical settings.
How is Silclear Tubing supplied?
The device is supplied in various packaging options including bulk, double packed, spooled and cut-to-length configurations to meet different application needs. This flexibility allows for customization based on specific requirements of medical procedures.
What is the regulatory status of Silclear Tubing?
Silclear Tubing has FDA 510(k) clearance with product code FPK and is classified as Class II. It is manufactured in Class 8 clean rooms in compliance with ISO 13485 quality standards, ensuring consistent quality and safety for medical applications.
Is Silclear Tubing reusable or single-use?
The device data does not specify whether Silclear Tubing is designed for single-use or reuse. However, as a fluid delivery device in medical applications, its reuse would depend on proper cleaning and sterilization protocols according to manufacturer instructions and regulatory guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Silicone Tubing | QMD Degania, QMD Degania Products | Silicone Catheters, Surgical Drains & Custom OEM ..., PDF FPK (51 O - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943992 | Class II | Active |
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Manufacturer
- Manufacturer
- Degania Silicone Ltd
- FDA Applicant
- Degania Silicone , Ltd.
Sources (1)
- FDA 510(k) K943992 24 fields · synced Sep 23, 2026