8 mm Assist Cannula; 12 mm Assist Cannula
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251490 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
- Models / Variants
- 8 mm Assist Cannula FDA 510(k)12 mm Assist Cannula 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 8 mm Assist Cannula and 12 mm Assist Cannula are surgical devices designed to establish a port of entry for instruments, endoscopes, or accessories. These cannulas facilitate access to the surgical site during endoscopic procedures.
These devices are supplied by Intuitive Surgical, Inc. and have received FDA 510(k) clearance. They are intended for use in gastroenterology and urology applications.
Frequently asked questions
What is the primary purpose of the Assist Cannula?
The 8 mm and 12 mm Assist Cannulas are designed to create a port of entry for surgical instruments, endoscopes, or accessories, allowing for access to the surgical site during endoscopic procedures.
Which medical specialties are these cannulas intended for?
These devices are specifically intended for use in gastroenterology and urology applications to facilitate endoscopic access.
What is the regulatory status of these devices?
The 8 mm and 12 mm Assist Cannulas have received FDA 510(k) clearance under the K-number K251490, indicating they have been found substantially equivalent to legally marketed predicate devices.
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: 8 mm Assist Cannula; 12 mm Assist Cannula (K251490) — FDA 510(k ..., PDF Intuitive Da Vinci X/Xi System Instrument and Accessory Catalog, 8 mm Assist Cannula; 12 mm Assist Cannula (K251490), PDF ® SURGICAL SYSTEM FIRST ACCES - Intuitive Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251490 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K251490 24 fields · synced Sep 22, 2026