Novatome, Model SU101-50
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072051 FDA 510(k)
- FDA Product Code
- DWZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4075 FDA 510(k)
- Regulation Number
- 870.4075 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novatome, Model SU101-50, is an endomyocardial biopsy device designed for the collection of tissue samples from the myocardium. Classified under the nomenclature for biopsy instruments, it is specifically intended for cardiovascular applications, facilitating diagnostic procedures in cardiac tissue analysis.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a classification as a Class II device. The Model SU101-50 is intended for use in clinical settings where precise myocardial tissue sampling is required, adhering to regulatory standards for cardiovascular diagnostic tools.
Frequently asked questions
What is the Novatome SU101-50 specifically used for in clinical practice?
The Novatome SU101-50 is designed exclusively for collecting myocardial tissue samples during endomyocardial biopsy procedures. It is intended for use in cardiovascular diagnostics, allowing clinicians to obtain precise tissue samples from the heart muscle for analysis, such as assessing inflammation, fibrosis, or rejection in cardiac conditions.
Is the Novatome SU101-50 intended for reuse or is it single-use only?
The Novatome SU101-50 is explicitly intended for single-use only. This ensures patient safety and sterility, as it is supplied sterile and not designed for reprocessing or reuse.
How is the Novatome SU101-50 regulated, and what does that mean for its use?
The Novatome SU101-50 is regulated under both the FDA’s 510(k) clearance process and the EU’s Medical Device Regulation (MDR), classified as a Class II device. This means it has undergone rigorous review by regulatory bodies to ensure safety and performance for its intended use in myocardial tissue sampling, adhering to strict standards for cardiovascular diagnostic tools.
What storage or handling considerations should be taken into account for the Novatome SU101-50?
Since the Novatome SU101-50 is supplied sterile and intended for single-use, it should be stored in its original packaging until use to maintain sterility. Proper handling, including avoiding contamination or exposure to moisture, is critical to preserve its integrity for clinical 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 | K072051 | Class II | Active |
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Manufacturer
- Manufacturer
- Scholten Surgical Instruments, Inc.
Sources (2)
- FDA 510(k) K072051 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026