Medi-Globe Sclerotherapy Needles
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K955558 FDA 510(k)
- FDA Product Code
- FBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medi-Globe Sclerotherapy Needles are Endoscopic Injection Needles designed for sclerotherapy procedures in gastroenterology and urology. These needles are used to inject sclerosing agents into vascular structures, such as varices or hemorrhoidal veins, to promote fibrosis and occlusion, thereby treating conditions like esophageal varices or hemorrhoids. Their precise design facilitates controlled delivery of therapeutic substances during endoscopic interventions.
These needles are supplied as single-use, sterile devices, intended for use in clinical settings where endoscopic procedures are performed. They are classified under FDA regulation 876.1500 and fall under Device Class II, with an FDA 510(k) clearance (K955558) granted in 1996 following a Substantially Equivalent determination by the Gastroenterology-Urology (GU) Advisory Committee. Multiple sizes and variants are available, as indicated by the associated registration numbers, ensuring compatibility with various procedural requirements.
Frequently asked questions
What are the Medi-Globe Sclerotherapy Needles used for?
These needles are designed specifically for sclerotherapy procedures in gastroenterology and urology. They are used to inject sclerosing agents into vascular structures, such as esophageal varices or hemorrhoidal veins, to induce fibrosis and occlusion. This helps treat conditions like bleeding varices or symptomatic hemorrhoids by promoting long-term closure of the targeted vessels.
Are the Medi-Globe Sclerotherapy Needles single-use or reusable?
The Medi-Globe Sclerotherapy Needles are supplied as single-use devices. This ensures patient safety by eliminating the risk of cross-contamination between procedures, which is critical in endoscopic interventions where sterility is paramount.
What sizes or variants are available for these needles?
Multiple sizes and variants of the Medi-Globe Sclerotherapy Needles are available, each corresponding to specific registration numbers (e.g., 3011193403, 1220592, etc.). These variations accommodate different procedural requirements, ensuring compatibility with various endoscopic tools and patient anatomies. The exact specifications for each variant can be referenced through the listed registration numbers.
How are these needles supplied and stored?
The needles are supplied sterile and ready for immediate single-use in clinical settings. They should be stored in a clean, dry environment, protected from physical damage and contamination. Proper packaging integrity must be maintained until use to preserve sterility. Follow manufacturer guidelines for storage conditions to ensure device performance and safety.
What regulatory pathway does the Medi-Globe Sclerotherapy Needles follow?
The Medi-Globe Sclerotherapy Needles are classified under FDA regulation 876.1500 and fall under Device Class II. They received FDA 510(k) clearance (K955558) in 1996 through a Substantially Equivalent determination by the Gastroenterology-Urology (GU) Advisory Committee. This clearance confirms their compliance with U.S. regulatory standards for endoscopic injection needles.
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: GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES (K955558) — FDA 510 (k ..., K955558 FDA 510 (k) - GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES, Gip/Medi-globe Sclerotherapy Needles - Beudamed, PDF K955558 - Gip/Medi-globe Sclerotherapy Needles, MEDI-GLOBE GMBH FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955558 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medi-Globe Corp.
Sources (1)
- FDA 510(k) K955558 24 fields · synced Oct 1, 2026