Identifiers
- 510(k) Number
- K121858 FDA 510(k)
- FDA Product Code
- HFG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4160 FDA 510(k)
- Regulation Number
- 884.4160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ablation System is a laparoscopic unipolar coagulator device used for radiofrequency ablation procedures. It is designed to perform ablation treatments in medical settings, particularly in the field of obstetrics and gynecology. The system utilizes electrosurgical radiofrequency technology to achieve tissue ablation.
The device is supplied as part of a system and is intended for single-use applications. It is not MRI compatible and requires appropriate storage conditions. The Ablation System has received FDA 510(k) clearance with the product code HFG and is classified as a class II medical device.
Frequently asked questions
What is the Ablation System used for?
The Ablation System is a laparoscopic unipolar coagulator device designed for radiofrequency ablation procedures, primarily in the field of obstetrics and gynecology. It utilizes electrosurgical radiofrequency technology to achieve tissue ablation in medical settings.
Is the Ablation System single-use or reusable?
The Ablation System is intended for single-use applications only. It is supplied as part of a system and should not be reused to ensure patient safety and device performance.
What are the storage requirements for the Ablation System?
The Ablation System requires appropriate storage conditions to maintain its integrity and functionality. However, specific storage details are not provided in the device data, so users should follow the manufacturer's instructions for proper storage.
What is the regulatory status of the Ablation System?
The Ablation System has received FDA 510(k) clearance with the product code HFG and is classified as a class II medical device. It was determined to be substantially equivalent to predicate devices for its intended use.
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: K121858 FDA 510(k) - THE ABLATION SYSTEM | Halt Medical, Inc., The Ablation System 510 (k) FDA Premarket Notification K121858 HALT ..., THE ABLATION SYSTEM (K121858) — FDA 510 (k) | Innolitics, Halt Medical, Inc. FDA 510 (k) Products (2010-2014), Study Details | NCT00874029 | Laparoscopic Radiofrequency Ablation (RFA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121858 | Class II | Active |
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Manufacturer
- Manufacturer
- Halt Medical, Inc
- FDA Applicant
- Halt Medical, Inc.
Sources (1)
- FDA 510(k) K121858 24 fields · synced Sep 22, 2026