510(k) · Cleared
ClearedThe Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halt Medical, Inc. · HFG Coagulator, Laparoscopic, Unipolar (And Accessories)
Cleared on Nov 5, 2012 as substantially equivalent to K094009 (Halt Medical, Inc., 2010) after a 132-day review. Its family tree reaches back 2 generations to 1999. 9 later devices descend from it.
- Decided
- Nov 5, 2012
- Review
- 132 days
- Class
- Class II
- Product code
- HFG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993944 (1999). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK993944 Rita Model 1500 Electrosurgical Generator, Power…Rita Medical Systems · 1999
- 1 generation backK094009 Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 2010
- This deviceK121858 The Ablation SystemHalt Medical, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
- Descendant · 5 generations on · 2 of its ownK233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018 · cites it directly6descendants
- K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020 · 2 generations on5descendants
- K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021 · 3 generations on4descendants
- K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022 · 4 generations on3descendants
- K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993944 | Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable… | Rita Medical Systems | 1999 | — |
| −1 | K094009 | Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI | Halt Medical, Inc. | 2010 | — |
| 0 (this device) | K121858 | The Ablation System | Halt Medical, Inc. | 2012 | — |
| +1 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018 | — |
| +2 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020 | — |
| +3 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021 | — |
| +4 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022 | — |
| +5 | K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HFG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K094009 | Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GISummary page 1…4160 Legally Marketed Device to which Halt 2000 GITM Electrosurgicat Radiofrequency Ablation substantial equivalence is claimed System (K094009) Intended Use The Acessa System is indicated for use in percutaneous, laparoscopic coagulation… | 2010 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173703 (Gynesonics, Inc., 2018) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HFG devicesHFG Coagulator, Laparoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HFG
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HFG
Too few HFG 510(k)s in any year since 2007 to give a median.
Recalls per year · HFG
No recall names HFG since 2007.
Adverse event reports per year · HFG
32in 2025
MAUDE reports naming product code HFG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121858: The Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121858
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026