Identifiers
- 510(k) Number
- K193520 FDA 510(k)
- FDA Product Code
- HIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1730 FDA 510(k)
- Regulation Number
- 884.1730 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EVA 15 Insufflator is a laparoscopic insufflator device designed to deliver a targeted and controlled pressure into the lumen or cavity of interest during endoscopic procedures. It is classified as a Class II medical device under FDA regulation number 884.1730 and is substantially equivalent to a predicate device.
The device is supplied by Palliare, Ltd. and has received FDA 510(k) clearance under K-number K193520. It is intended for use in obstetrics and gynecology settings and is not sterile, single-use, or MRI conditional unless explicitly stated in the labeling. Storage and handling should follow manufacturer instructions.
Frequently asked questions
What is the EVA 15 Insufflator used for?
The EVA 15 Insufflator is designed to deliver a targeted and controlled pressure into the lumen or cavity of interest during endoscopic procedures, specifically intended for use in obstetrics and gynecology settings as stated in the device description.
Is the EVA 15 Insufflator sterile or single-use?
The EVA 15 Insufflator is not sterile, single-use, or MRI conditional unless explicitly stated in the labeling, as clearly indicated in the device description under the DESCRIPTION section.
How is the EVA 15 Insufflator supplied and by whom?
The EVA 15 Insufflator is supplied by Palliare, Ltd., located at Galway Business Park, Dangan, Galway, H91 92DK, Ireland, as specified in the MANUFACTURER and address fields of the device data.
What regulatory clearance does the EVA 15 Insufflator have?
The EVA 15 Insufflator has received FDA 510(k) clearance under K-number K193520, as stated in the AUTHORIZATIONS and DESCRIPTION sections, and is classified as a Class II medical device under regulation number 884.1730.
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: The EVA Insufflator | Palliare, Home | Palliare, K193520 FDA 510 (k) - EVA 15 Insufflator | Palliare , Ltd., K232902 FDA 510(k) - EVA15 insufflator | Palliare , Ltd., EVA 15 Insufflator (K193520) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193520 | Class II | Active |
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Manufacturer
- Manufacturer
- Palliare , Ltd.
Sources (1)
- FDA 510(k) K193520 24 fields · synced Sep 24, 2026