Stone Extractor Balloon Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011261 FDA 510(k)
- FDA Product Code
- FGE 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 is a Stents, Drains and Dilators for the Biliary Ducts, classified as a Class II medical device. The Stone Extractor Balloon Catheter is designed to facilitate the removal of biliary or urinary stones via mechanical dilation and retrieval. Its inflatable balloon expands within the ductal system to engage and dislodge obstructions, allowing for extraction through endoscopic or percutaneous techniques. The device incorporates a multi-lumen tube with proximal connectors for contrast media, guidewire insertion, or inflation control, ensuring precise maneuverability and stability during procedures.
The Stone Extractor Balloon Catheter is supplied as a single-use, non-sterile device (sterilized prior to use) and is intended for use in gastroenterology and urology settings. Available in tube diameters of 5 Fr, 7 Fr, and 7.5 Fr, with total lengths of 200 cm, the balloon diameters range from 9–12 mm or 14–16 mm, depending on the variant. Some versions may contain latex, requiring caution for latex-sensitive patients. Regulated under FDA 510(k) clearance (K011261) and FDA regulation 876.5010, the device adheres to standard medical device compliance for biliary and urinary applications.
Frequently asked questions
What is the Stone Extractor Balloon Catheter used for?
The Stone Extractor Balloon Catheter is designed to remove biliary or urinary stones through mechanical dilation and retrieval. Its inflatable balloon expands within the ductal system to engage and dislodge obstructions, allowing stones to be extracted via endoscopic or percutaneous techniques. This is particularly useful in cases where stones are lodged and cannot be removed by other methods alone.
How is the Stone Extractor Balloon Catheter supplied, and is it sterile?
The device is supplied as a single-use, non-sterile item that is sterilized prior to use. This means it must be sterilized by the healthcare facility before use to ensure safety and compliance with medical standards. The packaging indicates it is not pre-sterilized, so proper sterilization protocols must be followed.
What sizes and models are available for the Stone Extractor Balloon Catheter?
The Stone Extractor Balloon Catheter is available in three tube diameters: 5 Fr, 7 Fr, and 7.5 Fr, each with a total length of 200 cm. The balloon diameters vary depending on the variant, ranging from 9–12 mm or 14–16 mm. These variations allow clinicians to select the appropriate size for the specific anatomical and procedural requirements of the patient.
Does the Stone Extractor Balloon Catheter contain latex, and what precautions should be taken?
Some versions of the Stone Extractor Balloon Catheter may contain latex. If latex sensitivity is a concern for the patient, clinicians should verify the specific model being used and take appropriate precautions, such as using latex-free alternatives or ensuring the procedure is conducted in a latex-free environment to prevent allergic reactions.
How should the Stone Extractor Balloon Catheter be stored?
Since the device is non-sterile and must be sterilized prior to use, it should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. The packaging should remain intact until sterilization to maintain its integrity and prevent contamination. Follow manufacturer guidelines for storage conditions to ensure optimal performance and safety.
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: Stone Extraction Balloons - Medi-Globe, Stone Extraction - Medi-Globe, K011261 FDA 510 (k) - STONE EXTRACTOR BALLOON CATHETER, PDF Stone Extraction Balloons - GULFROCK MEDICAL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011261 | Class II | Active |
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Manufacturer
- Manufacturer
- Medi-Globe Corp.
Sources (1)
- FDA 510(k) K011261 24 fields · synced Oct 1, 2026