Kii Structural Balloon Access System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252442 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Kii Structural Balloon Access System is a device used for tissue separation during inguinal hernia repair surgery. It features fully removable seals, first entry insufflation, and fixation technologies. The system is designed to be inserted into an incision with the balloon for surgical procedures.
The device is supplied as part of Applied Medical's access systems portfolio and is intended for use in general, bariatric, colorectal, urologic, and gynecologic surgeries. It received FDA 510(k) clearance with the K number K252442 and is classified under product code GCJ. The device is substantially equivalent to the predicate Auto Suture Structural Balloon Trocar.
Frequently asked questions
What is the Kii Structural Balloon Access System used for?
The Kii Structural Balloon Access System is designed for tissue separation during inguinal hernia repair surgery. It features fully removable seals, first entry insufflation, and fixation technologies to facilitate surgical procedures through an incision.
In which surgical specialties can the Kii Structural Balloon Access System be used?
The system is intended for use in general, bariatric, colorectal, urologic, and gynecologic surgeries. Its versatile design makes it suitable for various surgical procedures requiring tissue separation and access.
What is the regulatory status of the Kii Structural Balloon Access System?
The Kii Structural Balloon Access System has received FDA 510(k) clearance with K number K252442. It is classified under product code GCJ and is substantially equivalent to the predicate Auto Suture Structural Balloon Trocar.
How is the Kii Structural Balloon Access System supplied?
The device is supplied as part of Applied Medical's access systems portfolio. It is designed to be inserted into an incision with the balloon component for surgical procedures, though specific packaging details aren't provided in the available information.
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: Kii Access Systems - Applied Medical, PDF October 31, 2025 Applied Medical Resources Corp. 22872 Avenida Empresa ..., PDF Kii Structural Balloon Access System K
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252442 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K252442 24 fields · synced Sep 25, 2026