Identifiers
- 510(k) Number
- K221995 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 Gas Insufflator is a Laparoscopic Insufflator, a Class II medical device designed to introduce gas into the abdominal or pelvic cavity during minimally invasive surgical procedures. It facilitates pneumoperitoneum by delivering controlled volumes of carbon dioxide or other inert gases, ensuring adequate working space for laparoscopic instruments while maintaining patient safety through pressure regulation.
This device is intended for use in Obstetrics/Gynecology procedures and is supplied as a reusable instrument, adhering to FDA 510(k) clearance and MDR compliance. It is non-sterile as supplied and must be sterilized before first use, typically via autoclave or ethylene oxide. The device is MRI-unsafe and must be removed from the patient prior to MRI imaging. Multiple flow rates and pressure settings are available, with regulatory registration numbers including 1221051 and 3030447506 under regulation 884.1730.
Frequently asked questions
What types of surgical procedures is this Gas Insufflator primarily used for, and why is it important for those procedures?
The Gas Insufflator is designed for Obstetrics/Gynecology procedures, specifically to create pneumoperitoneum during minimally invasive surgeries. It introduces controlled gas (like carbon dioxide) into the abdominal or pelvic cavity, ensuring adequate working space for laparoscopic instruments while maintaining patient safety through precise pressure regulation. This is critical for procedures like hysterectomies, ovarian cyst removals, or other gynecological surgeries where clear visualization and access are essential.
Is this device single-use or reusable, and what sterilization methods are recommended before first use?
This Gas Insufflator is reusable, meaning it can be used multiple times after proper sterilization. Since it is non-sterile as supplied, it must be sterilized before its first use. The manufacturer recommends standard sterilization methods such as autoclaving or ethylene oxide, which are commonly used for reusable medical devices. Always follow the manufacturer’s instructions for sterilization to ensure safety and functionality.
What safety considerations should be taken into account when using this device, particularly regarding MRI compatibility?
This Gas Insufflator is MRI-unsafe, meaning it must be completely removed from the patient before undergoing MRI imaging. The device contains materials that could interfere with MRI scans or pose a risk to the patient if left in place. Always confirm its removal and follow facility protocols for MRI-safe procedures when this device is involved.
What regulatory pathways has this device followed, and how does that affect its use in clinical settings?
The Gas Insufflator has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming it meets regulatory standards for safety and performance. This means it has been evaluated by authorities to ensure it is substantially equivalent to existing devices in its class (Laparoscopic Insufflators) and adheres to strict manufacturing and performance requirements. Clinicians can rely on its regulatory approvals when selecting it for Obstetrics/Gynecology 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221995 | Class II | Active |
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Manufacturer
Sources (2)
- FDA 510(k) K221995 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026