All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes And Cwv Re…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980917 FDA 510(k)
- FDA Product Code
- GCA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device comprises silicone drainage tubes and reservoirs designed for surgical use. It includes Penrose drains, CWV (Cholecystostomy or Common Bile Duct) drainage tubes, and thoracic drain tubes, as well as CWV reservoirs. These components facilitate fluid drainage from anatomical sites such as the biliary system, abdomen, or thoracic cavity, aiding postoperative recovery by preventing obstruction and managing postoperative edema.
The device is supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA regulations (510(k) clearance, K980917) and adheres to the Medical Device Directive (MDD). Tubes and reservoirs are available in various sizes and configurations, including T, Y, and T-Y drainage tubes, to accommodate different surgical procedures. Storage and handling must comply with sterile medical device protocols to ensure safety and efficacy.
Frequently asked questions
Are these drainage tubes reusable, or are they meant for single-use only?
These silicone drainage tubes, including Penrose drains, CWV drains, thoracic drains, and CWV reservoirs, are explicitly supplied sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer to maintain sterility and safety as outlined in the device description.
What types of drainage configurations are available, and how do they differ?
The device offers multiple configurations, including T, Y, and T-Y drainage tubes, which cater to different surgical needs. For example, T-tubes are often used for biliary drainage, while Y or T-Y configurations may provide additional branching for complex drainage pathways, such as in abdominal or thoracic procedures. The specific configuration depends on the anatomical site and surgical requirements.
How should these drainage systems be stored to ensure they remain sterile and functional?
Since these devices are sterile and single-use, they must be stored in accordance with sterile medical device protocols. This includes keeping them in their original, sealed packaging away from direct sunlight, moisture, and extreme temperatures. Always follow the manufacturer’s instructions for storage to preserve sterility and integrity until use.
What anatomical sites are these drainage tubes primarily designed for, and how do they assist in recovery?
These silicone drainage tubes are designed for postoperative fluid drainage from anatomical sites like the biliary system (e.g., gallbladder or bile ducts), abdomen, or thoracic cavity. They help prevent obstruction, manage postoperative edema, and facilitate recovery by ensuring proper fluid evacuation, reducing complications such as infection or swelling.
What regulatory pathways have these devices undergone, and which committees were involved?
These devices were cleared through the FDA’s 510(k) pathway (K980917) under the Traditional review process, with a substantially equivalent determination. The Gastroenterology and Urology (GU) advisory committee reviewed the submission, and the device also complies with the Medical Device Directive (MDD) in international markets. These pathways ensure the device meets safety and performance standards for its intended use.
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: All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes ..., All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes ..., All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes ..., PDF K980917 All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain ..., FDA 510 (k) Applications Submitted by FORTUNE MEDICAL INSTRUMENT CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K980917 | Class II | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (2)
- FDA 510(k) K980917 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026