SERF Ablation Needle
by Thermedical
510(k) K120116
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120116 | Date1 Oct 2012 | 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- Withdrawn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
- Full name
- Serf Ablation System Serf Ablation Needle
- 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, 19 Sep 2026
The SERF Ablation Needle is a radiofrequency ablation needle designed for intramyocardial delivery of thermal energy. It incorporates a 25-gauge stainless steel needle with 30 side holes, used in conjunction with heated saline to create controlled tissue ablation. This device is intended for use within the SERF Ablation System to treat refractory ventricular arrhythmias.
The needle is supplied as part of the SERF Ablation System and is intended for single-use in a clinical electrophysiology setting. It is not sterile at time of shipment but must be sterilized prior to use, adhering to standard medical device sterilization protocols. The device carries an FDA 510(k) clearance under product code GEI, with no specific MRI safety classification noted. Storage and handling follow standard sterile medical device procedures.
Questions
AI-generated answers, 19 Sep 2026
What is the SERF Ablation Needle used for in a clinical setting?
The SERF Ablation Needle is designed for intramyocardial radiofrequency ablation to deliver controlled thermal energy to the heart tissue. It is specifically intended for treating refractory ventricular arrhythmias as part of the SERF Ablation System in electrophysiology procedures. The needle uses heated saline through its 30 side holes to create precise tissue ablation.
Is the SERF Ablation Needle sterile when it arrives, and how should it be prepared for use?
No, the SERF Ablation Needle is not sterile at shipment and must be sterilized prior to use. It follows standard medical device sterilization protocols to ensure safety before clinical application. Always adhere to established sterilization guidelines for reusable or single-use devices in your facility.
Can the SERF Ablation Needle be reused, or is it intended for single-use only?
The SERF Ablation Needle is intended for single-use in a clinical electrophysiology setting. While it is not explicitly labeled as disposable, its design and intended use align with single-use medical devices, and reuse is not recommended or supported by the manufacturer.
What are the key specifications of the SERF Ablation Needle, particularly its physical construction?
The needle features a 25-gauge stainless steel shaft with 30 side holes for saline delivery. It is part of the SERF Ablation System and works by infusing heated saline to generate controlled thermal ablation within cardiac tissue. The needle’s gauge and hole configuration are optimized for precise intramyocardial energy deposition.
How should the SERF Ablation Needle be stored, and are there any special handling requirements?
The needle must be stored and handled according to standard sterile medical device procedures, as it requires sterilization before use. Storage conditions should protect it from contamination, moisture, and physical damage. Follow your facility’s protocols for sterile device storage to maintain integrity until sterilization.