Identifiers
- 510(k) Number
- K002018 FDA 510(k)
- FDA Product Code
- FED 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 NDO Surgical Overtube is classified as an Endoscopic Access Overtube, designed to provide a protective channel for endoscopic procedures. Constructed from extruded, flexible polyvinyl chloride (PVC) reinforced with stainless steel wire braiding, it ensures durability and stability during repeated intubations. The device is intended to encase an endoscope or endoscopic instruments, reducing friction and potential damage during insertion and manipulation within the gastrointestinal tract.
This overtube is inserted through the patient’s mouth into the esophagus by a physician during endoscopic procedures. Supplied as a single-use device, it is non-sterile and requires terminal sterilization prior to use. The device is regulated under FDA 510(k) clearance (K002018) and falls under Class II medical device classification (876.1500). Multiple sizes and configurations are available, as indicated by the associated registration numbers, to accommodate various endoscopic applications in gastroenterology and urology.
Frequently asked questions
What is the NDO Surgical Overtube used for?
The NDO Surgical Overtube is designed as an Endoscopic Access Overtube to encase and protect endoscopes or endoscopic instruments during procedures in the gastrointestinal (GI) tract and urology applications. Its flexible PVC construction with stainless steel wire braiding reduces friction and minimizes potential damage to the endoscope during insertion and manipulation, ensuring smoother and safer procedures.
How is the NDO Surgical Overtube supplied, and what are its sterility requirements?
The NDO Surgical Overtube is supplied as a single-use device in a non-sterile state. Since it is intended for direct patient contact, terminal sterilization must be performed before use to ensure sterility. Follow manufacturer guidelines for the appropriate sterilization method to maintain device integrity and safety.
Are multiple sizes available, and how do I select the right one?
Yes, the NDO Surgical Overtube comes in multiple sizes and configurations, each identified by a unique registration number (e.g., 3005173255, 3012649202). The correct size depends on the specific endoscopic procedure and patient anatomy. Consult the product documentation or manufacturer for compatibility with your endoscope and intended use in gastroenterology or urology.
Can the NDO Surgical Overtube be reused, or is it intended for one-time use?
The NDO Surgical Overtube is explicitly designed for single-use only. Its flexible PVC and braided construction are optimized for durability during a single procedure, but reuse is not recommended or supported by the manufacturer. Reuse risks contamination, structural compromise, and potential patient harm, so adherence to single-use guidelines is critical.
How should the NDO Surgical Overtube be stored before use?
The device should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Avoid exposure to chemicals or moisture, as these can degrade the PVC material or compromise sterility. Terminal sterilization must be performed immediately before use, as the overtube is non-sterile at the time of packaging.
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: NDO SURGICAL SURGICAL OVERTUBE by SURGICAL, INC. | FDA 510 (k) Summary, FDA Browser - Cleared 510 (K) - NDO SURGICAL SURGICAL OVERTUBE (K002018), fda.innolitics.com, PDF OverTube O - bostonscientific.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002018 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgical, Inc.
Sources (1)
- FDA 510(k) K002018 24 fields · synced Oct 1, 2026