PneuVIEW XE VeryClear Gas Evacuation Cannula
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132203 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 PneuVIEW XE VeryClear Gas Evacuation Cannula is a laparoscopic insufflator designed to facilitate gas evacuation during minimally invasive surgical procedures. It provides a pathway for endoscopic instruments while removing smoke and plume generated in the surgical cavity, thereby enhancing visualization for the surgeon.
This device is intended for use in thoracic, abdominal, and gynecologic endoscopic surgeries. Supplied as a single-use item, it is non-sterile and requires sterilization prior to use. The cannula is classified as Class II under FDA regulations (884.1730) and has received FDA 510(k) clearance and MDD compliance. It is supplied in sterile packaging and must be stored according to manufacturer instructions to maintain integrity.
Frequently asked questions
Is the PneuVIEW XE VeryClear Gas Evacuation Cannula intended for use in specific types of surgeries, and if so, which ones?
Yes, this device is specifically designed for use in minimally invasive surgeries within the thoracic, abdominal, and gynecologic endoscopic procedures. It helps improve visualization by evacuating smoke and plume generated during these surgeries while allowing endoscopic instruments to pass through.
How is the PneuVIEW XE VeryClear Gas Evacuation Cannula supplied, and is it reusable?
The cannula is supplied as a single-use item, but it is non-sterile and requires sterilization prior to use. It comes in sterile packaging, so it must be handled carefully to maintain its integrity before sterilization.
What storage instructions should be followed to ensure the device remains intact before use?
The device must be stored according to the manufacturer’s instructions to preserve its sterile packaging and integrity. Since it is non-sterile as supplied, proper storage ensures it remains ready for sterilization before use.
What regulatory pathways has the PneuVIEW XE VeryClear Gas Evacuation Cannula followed, and what does that mean for its use?
The device has received FDA 510(k) clearance and complies with the MDD (Medical Device Directive). It is classified as Class II under FDA regulations (884.1730), meaning it has undergone substantial equivalence review through the Obstetrics/Gynecology (OB) advisory committee before clearance.
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: PDF Section 1. Summary and Certification, PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA (K132203) — FDA 510 (k ..., PDF Section 1. Summary and Certification
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 | K132203 | Class II | Active |
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Manufacturer
- Manufacturer
- Lexion Medical LLC
- FDA Applicant
- Lexion Medical, LLC
Sources (2)
- FDA 510(k) K132203 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026