K121858 is an FDA 510(k) clearance for the THE ABLATION SYSTEM. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.
Submitted by Halt Medical, Inc. (Brentwood, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 132 days - within the typical 510(k) review window.
This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.
NCT00874029
Completed
Interventional
Industry-sponsored
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation
| Condition studied |
Uterine Fibroids; Uterine Myomas |
| Study design |
Single group |
| Eligibility |
Female only
· 25 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Mary Hinckley, MD |
| Sponsor |
Acessa Health, Inc.
(industry)
|
Started 2009-03-01
→
Primary completion 2012-01-01
→
Completed 2014-03-01
Primary outcome
Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
Secondary outcome
Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)
View full study on ClinicalTrials.gov