Endopass Endoscopic Delivery Instrument, Model P/N 400170
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040948 FDA 510(k)
- FDA Product Code
- NAY 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 Endopass Endoscopic Delivery Instrument (Model P/N 400170) is a surgical device designed for endoscopic procedures. It facilitates the delivery of medical instruments or devices through natural orifices or small incisions, enabling minimally invasive interventions in gastroenterology and urology. Its primary function is to assist in the precise placement of tools within the body, reducing trauma and improving procedural outcomes.
This instrument is supplied as a reusable medical device and is intended for use in controlled clinical settings, such as operating rooms or endoscopy suites. It is classified under Class II with Special Controls and has received FDA 510(k) clearance. The device is not MRI-safe, and its use requires adherence to standard sterilization protocols. It is distributed exclusively by Intuitive Surgical, Inc., and its specifications are governed by regulatory standards outlined under regulation number 876.1500.
Frequently asked questions
What is the Endopass Endoscopic Delivery Instrument (P/N 400170) used for?
The Endopass Endoscopic Delivery Instrument (P/N 400170) is designed to assist in endoscopic procedures within gastroenterology and urology. It facilitates the precise delivery of medical instruments or devices through natural orifices or small incisions, enabling minimally invasive interventions. This reduces trauma to the patient and enhances procedural outcomes by allowing controlled placement of tools within the body.
Is the Endopass Endoscopic Delivery Instrument reusable or single-use?
The Endopass Endoscopic Delivery Instrument (P/N 400170) is supplied as a reusable medical device. It is intended for use in controlled clinical settings like operating rooms or endoscopy suites, where it can be sterilized and reused following standard sterilization protocols. Reusability helps optimize cost efficiency and resource management in healthcare environments.
What sterilization methods are required for the Endopass Endoscopic Delivery Instrument?
The Endopass Endoscopic Delivery Instrument (P/N 400170) requires adherence to standard sterilization protocols to ensure safety and efficacy. Since it is reusable, it must be thoroughly cleaned and sterilized between uses, typically using methods such as autoclaving, ethylene oxide, or other approved sterilization techniques. Always follow manufacturer guidelines and regulatory standards to maintain sterility and functionality.
Is the Endopass Endoscopic Delivery Instrument MRI-safe?
No, the Endopass Endoscopic Delivery Instrument (P/N 400170) is not MRI-safe. This means it should not be used or placed in an MRI environment, as it may interfere with MRI imaging or pose risks during the procedure. Always verify compatibility with imaging equipment before use.
Who distributes the Endopass Endoscopic Delivery Instrument, and where is it governed by regulatory standards?
The Endopass Endoscopic Delivery Instrument (P/N 400170) is exclusively distributed by Intuitive Surgical, Inc. Its specifications and regulatory compliance are governed by the standards outlined under regulation number 876.1500. This ensures adherence to safety, performance, and quality requirements set by regulatory authorities.
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: K040948 FDA 510(k) - INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC ..., Intuitive | Maker of Da Vinci & Ion Robotic Systems, Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040948 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K040948 24 fields · synced Oct 1, 2026