CoreCath 2.7S
510(k) K170296
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170296 | Date20 Mar 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CoreCath 2.7S is an electrosurgery catheter designed for airway use, combining coagulation and cutting functions in a single-use device. Its integrated suction port facilitates the evacuation of carbonized tissue and smoke during procedures, enabling precise and controlled tissue management in bronchoscopic interventions. This device is intended for use in endoscopic airway applications where both ablation and suction capabilities are required.
Supplied as a single-use device, the CoreCath 2.7S is intended for sterile use within bronchoscopic settings. It is regulated under FDA 510(k) clearance (K170296) as a substantially equivalent device in the General, Plastic Surgery category. The device’s specifications and intended use align with radiation-emitting product classifications, adhering to relevant CFR Title 21 standards. No additional regulatory markings or approvals beyond the stated 510(k) clearance are provided.
Other devices from Medtronic Advanced Energy
Questions
AI-generated answers, 1 Oct 2026
What is the CoreCath 2.7S designed for in bronchoscopic procedures?
The CoreCath 2.7S is specifically designed for airway use in bronchoscopic interventions. It integrates coagulation and cutting functions to enable precise tissue management. The device’s integrated suction port allows for the simultaneous evacuation of carbonized tissue and smoke, improving visibility and control during procedures where both ablation and suction are required.
Is the CoreCath 2.7S intended for single-use or reusable applications?
The CoreCath 2.7S is supplied as a single-use device. This design ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for sterile medical instruments in bronchoscopic settings.
How does the suction feature of the CoreCath 2.7S benefit clinical workflow?
The integrated suction port in the CoreCath 2.7S removes carbonized tissue and smoke in real time, which enhances procedural clarity and reduces the need for manual suctioning. This streamlines workflow by maintaining a clear field of view and minimizing interruptions during ablation, improving both efficiency and patient safety.
What regulatory pathway does the CoreCath 2.7S follow, and what does this mean for clinicians?
The CoreCath 2.7S is cleared under the FDA’s 510(k) pathway (K170296) as substantially equivalent to a predicate device in the General, Plastic Surgery category. This clearance confirms that the device meets established safety and effectiveness standards for its intended use in airway electrosurgery, ensuring clinicians can rely on its performance and compliance with regulatory requirements.
Are there specific storage requirements for the CoreCath 2.7S before use?
While the provided data does not specify storage conditions, single-use electrosurgical devices like the CoreCath 2.7S are generally recommended to be stored in a clean, dry environment protected from direct sunlight and extreme temperatures. Ensure the packaging remains intact until immediate use to maintain sterility and functionality.