Cryoseal FS Applicator System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071126 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CryoSeal FS Applicator System is composed of a thermoplastic polystyrene applicator handle and two types of dispensing tips with a Y-body manifold for application of the fibrin sealant. It includes line/drop tips in 5 and 10 cm lengths and spray tips in three configurations.
The system is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection. It is supplied as a device system with FDA 510(k) clearance under K071126 and product code FMF.
Frequently asked questions
What is the CryoSeal FS Applicator System used for?
It is intended for the simultaneous application of the two components of CryoSeal FS fibrin sealant onto the incised liver surface during liver resection procedures.
What components make up the CryoSeal FS Applicator System?
The system consists of a thermoplastic polystyrene applicator handle, a Y-body manifold, and two types of dispensing tips: line/drop tips in 5 and 10 cm lengths and spray tips in three configurations.
How is the CryoSeal FS Applicator System supplied and cleared for use?
It is supplied as a complete device system and has FDA 510(k) clearance under K071126 with product code FMF, indicating it is substantially equivalent to a legally marketed device.
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: CRYOSEAL FS APPLICATOR SYSTEM by THERMOGENESIS CORP. | FDA 510 (k) Summary, PDF 510 (k) SUMMARY- CryoSeal® FS Applicator System ko7' i Ž4 Submitter ..., CryoSeal FS System | FDA, BP060001/0: CryoSeal FS System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071126 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermogenesis Corp.
Sources (1)
- FDA 510(k) K071126 24 fields · synced Sep 24, 2026