Neoclose Hasson, Neoclose Universal
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123280 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 Neoclose Hasson, Neoclose Universal is a surgical closure device designed for securing trocar incisions and laparoscopic ports in general and plastic surgery procedures. It features a Hasson-style trocar closure mechanism and a universal application for various incision sizes, providing a reliable method to prevent air leaks and maintain pneumoperitoneum during minimally invasive surgeries.
This device is supplied as a sterile, single-use product and is intended for use in operating room settings. It is classified under product code GCJ (General & Plastic Surgery) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The device is available in specific configurations tailored for Hasson trocars and universal port closure applications, with no MRI safety restrictions noted. Storage and handling follow standard sterile surgical instrument protocols.
Frequently asked questions
What is the Neoclose Hasson designed for?
The Neoclose Hasson is specifically engineered to secure trocar incisions and laparoscopic ports in general and plastic surgery procedures. Its Hasson-style closure mechanism ensures a tight seal around the trocar, preventing air leaks and helping maintain pneumoperitoneum—critical for stable laparoscopic conditions during minimally invasive surgeries.
How is the Neoclose Universal different from the Hasson model?
The Neoclose Universal is designed for broader application across various incision sizes, whereas the Hasson model is tailored exclusively for Hasson trocars. Both share the same purpose of preventing air leaks, but the Universal version offers flexibility for different port types, making it adaptable to a wider range of surgical setups.
Is the Neoclose device sterile and single-use?
Yes, the Neoclose Hasson and Universal devices are supplied as sterile, single-use products. This ensures patient safety by eliminating cross-contamination risks and adheres to standard operating room protocols for surgical instruments.
What storage and handling guidelines apply to this device?
The Neoclose devices must be stored and handled according to standard sterile surgical instrument protocols. This includes maintaining the sterile barrier until use, storing in a clean, dry environment away from direct sunlight or extreme temperatures, and following manufacturer instructions to preserve sterility and functionality.
Are there any MRI safety restrictions for the Neoclose Hasson or Universal?
No MRI safety restrictions are noted for either the Neoclose Hasson or Universal devices. However, as with all surgical instruments, clinicians should verify compatibility with their specific MRI system and protocols before use in an MRI environment.
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: NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K131688) — FDA 510 (k) | Innolitics, Neoclose Hasson, Neoclose Universal 510 (k) FDA Premarket Notification ..., Neosurgical, Ltd. FDA 510 (k) Products (2013-2018)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123280 | Class II | Active |
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Manufacturer
- Manufacturer
- Neosurgical, Ltd.
Sources (1)
- FDA 510(k) K123280 24 fields · synced Oct 1, 2026