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Omniflator Model 6600

FDA 510(k)

Class II (US FDA 510(k))

510(k) K935862

by Northgate Technologies Inc.

Identifiers

510(k) Number
K935862 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 Omniflator Model 6600 is a laparoscopic insufflator, a Class II medical device designed to introduce gas into the peritoneal cavity during minimally invasive surgical procedures. It facilitates visualization and access by creating and maintaining pneumoperitoneum, enabling safe manipulation of laparoscopic instruments.

This device is intended for single-use in surgical settings and is regulated under FDA 510(k) clearance (K935862) under Product Code HIF. It operates using CO₂ gas, as indicated by associated supply references, and is not intended for MRI environments. Supplied sterile, it requires proper storage and handling in accordance with manufacturer guidelines to ensure functionality and safety.

Frequently asked questions

What types of surgical procedures is the Omniflator Model 6600 primarily used for, and why is it important in those settings?

The Omniflator Model 6600 is designed for laparoscopic procedures, specifically to introduce gas into the peritoneal cavity during minimally invasive surgeries. It creates and maintains pneumoperitoneum, which improves visualization and workspace for surgeons, enabling safer manipulation of laparoscopic instruments. Its primary use aligns with obstetrics/gynecology procedures, where clear access and visibility are critical.

Is the Omniflator Model 6600 reusable, or is it intended for single-use only? How does this affect its handling and storage?

The Omniflator Model 6600 is explicitly intended for single-use only in surgical settings. This design ensures patient safety and sterility, as reuse could compromise integrity and introduce contamination risks. Proper storage in accordance with manufacturer guidelines is essential to maintain functionality and sterility until use.

What gas does the Omniflator Model 6600 use, and are there any restrictions on its use in specific environments like MRI facilities?

The Omniflator Model 6600 operates using CO₂ gas, as referenced in its specifications. It is not intended for use in MRI environments, as the device’s materials or function may not be compatible with magnetic resonance imaging systems. Always verify the surgical setting’s compatibility before use.

How is the Omniflator Model 6600 supplied, and what should clinicians check before opening the packaging?

The Omniflator Model 6600 is supplied sterile and ready for immediate single-use. Clinicians should verify the packaging integrity (e.g., seals, labels) before opening to confirm sterility and ensure no damage occurred during storage or transport. Improper handling could compromise its sterile condition.

What regulatory pathway does the Omniflator Model 6600 follow, and what does this mean for its use in clinical practice?

The Omniflator Model 6600 is regulated under the FDA 510(k) clearance pathway (K935862) and classified as a Class II medical device. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for laparoscopic insufflation. Clinicians can rely on its regulatory clearance as evidence of its intended use and compliance with U.S. medical device regulations.

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: NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 (K935862) — FDA 510 (k ..., NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 510(k) K935862 - fda.report, PDF K935862 - Northgate Technologies Omniflator Model 6600, FDA Browser - Cleared 510 (K) - NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL ..., Northgate Technologies Inc. FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Northgate Technologies Inc.
FDA Applicant
Northgate Technologies, Inc.

Sources (1)

  • FDA 510(k) K935862 24 fields · synced Sep 20, 2026