DuploSpray MIS Applicator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061092 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DuploSpray MIS Applicator is a disposable medical device classified as a spray applicator (Product Code: FMF). It consists of a rigid stainless steel cannula, tubing set, and replaceable tip designed to deliver a thin, uniform spray for precise application in surgical settings. This device is intended for use in minimally invasive procedures where broad area coverage is required, ensuring efficient product utilization.
The DuploSpray MIS Applicator is supplied sterile via ethylene oxide (EO) sterilization and is intended for single-use only. It is compatible with the DuploSpray MIS Regulator and features a snap-lock mechanism (e.g., 30cm length). The device is regulated under FDA 510(k) clearance (K061092) and complies with the Medical Device Directive (MDD). Usage requires monitoring of vital signs to mitigate risks such as gas embolism during pressurized application.
Frequently asked questions
What types of surgical procedures is the DuploSpray MIS Applicator designed to assist with, and why is the spray pattern important in these settings?
The DuploSpray MIS Applicator is designed for use in minimally invasive procedures (MIS) where broad area coverage is required, such as arthroscopic surgeries or joint lavage. The thin, uniform spray pattern ensures precise and efficient application of substances (e.g., irrigation fluids or medications) while minimizing waste. This is particularly useful in confined spaces where traditional applicators may not distribute coverage evenly, reducing the risk of incomplete treatment or overapplication.
Is the DuploSpray MIS Applicator reusable, or is it intended for single-use only? How does this affect its sterilization and handling?
The DuploSpray MIS Applicator is intended for single-use only, as explicitly stated in its design. It is supplied sterile via ethylene oxide (EO) sterilization, meaning it should not be cleaned, reprocessed, or reused after one application. This ensures patient safety and maintains the device’s performance, as reuse could compromise sterility and integrity. Always follow single-use protocols to avoid contamination risks.
What are the key components of the DuploSpray MIS Applicator, and how does the snap-lock mechanism contribute to its functionality?
The DuploSpray MIS Applicator consists of three main parts: a rigid stainless steel cannula, a tubing set, and a replaceable tip. The snap-lock mechanism (e.g., the 30cm length variant) allows for secure, quick attachment to the DuploSpray MIS Regulator, ensuring a stable connection during pressurized application. This design minimizes leaks and simplifies setup, which is critical in time-sensitive surgical environments where reliability is paramount.
How should the DuploSpray MIS Applicator be stored, and what precautions should be taken to maintain its sterility before use?
While the device’s sterility via ethylene oxide (EO) sterilization is preserved until first use, storage should follow standard single-use medical device protocols: keep the applicator in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by preventing contact with unsterile surfaces or instruments. Once opened, use immediately to prevent exposure to airborne particles or microbial growth.
What safety considerations should clinicians be aware of when using the DuploSpray MIS Applicator, particularly regarding pressurized application?
During use, clinicians must monitor vital signs to mitigate risks associated with pressurized application, such as gas embolism. The device’s design—paired with the DuploSpray MIS Regulator—requires careful control of spray pressure to avoid introducing air or gas into the patient’s circulatory system. Always adhere to manufacturer guidelines for pressure limits and ensure proper technique to minimize complications during minimally invasive procedures.
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: Product Catalog - Baxter, Product Catalog - Baxter, baxter DuploSpray MIS Instructions For Use Manual, PDF DuploSpray MIS Applicator - support.baxter.com, PDF DuploSpray MIS
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K061092 | Class II | Active |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
Sources (2)
- FDA 510(k) K061092 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026