510(k) · Cleared
ClearedAcessa ProVu System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acessa Health, Inc. · HFG Coagulator, Laparoscopic, Unipolar (And Accessories)
Cleared on Sep 28, 2018 as substantially equivalent to K132744 (Halt Medical, Inc., 2014) and 2 other predicates after a 151-day review. Its family tree reaches back 16 generations to 1993.
- Decided
- Sep 28, 2018
- Review
- 151 days
- Class
- Class II
- Product code
- HFG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K924432 (1993). 49 ancestors in all, the oldest K882383 (1988). No later device cites it as a predicate yet.
- Root · 16 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 12 generations between
- 3 generations backK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 2 generations backK113184 Logicscan 64 Logicscan 128Telemed · 2012
- 1 generation backK163121 SmartUs EXT-1M/3MTelemed · 2017
- This deviceK181124 Acessa ProVu SystemAcessa Health, Inc. · 2018
Show all 16 generations
- Root · 16 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 15 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 14 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 13 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 12 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 11 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 10 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 9 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 8 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 7 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 6 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 5 generations backK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 4 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 3 generations backK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 2 generations backK113184 Logicscan 64 Logicscan 128Telemed · 2012
- 1 generation backK163121 SmartUs EXT-1M/3MTelemed · 2017
- This deviceK181124 Acessa ProVu SystemAcessa Health, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −15 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −14 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −13 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −12 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −11 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −10 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −9 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −8 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −7 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −6 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −5 | K093714 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −4 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −3 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −2 | K113184 | Logicscan 64 Logicscan 128 | Telemed | 2012 | — |
| −1 | K163121 | SmartUs EXT-1M/3M | Telemed | 2017 | — |
| 0 (this device) | K181124 | Acessa ProVu System | Acessa Health, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K132744 | Acessa Guidance SystemSummary page 4…Codes: OEW, IYO, ITX Classification Panel: Obstetrics and Gynecology Legally Marketed Primary Predicate: (Unmodified) Devices to K132744 Acessa Guidance System Which Substantial Equivalence Secondary Predicates: is Claimed: K121858 The Acessa S… | 2014 |
| * | K121858 | The Ablation SystemSummary page 4…Primary Predicate: (Unmodified) Devices to K132744 Acessa Guidance System Which Substantial Equivalence Secondary Predicates: is Claimed: K121858 The Acessa System K163121 Telemed SmartUS Ultrasound System The p… | 2012 |
| * | K163121 | SmartUs EXT-1M/3MSummary page 4…44 Acessa Guidance System Which Substantial Equivalence Secondary Predicates: is Claimed: K121858 The Acessa System K163121 Telemed SmartUS Ultrasound System The predicate devices have not been subject to a design… | 2017 |
| † | K093488 | Aloka Prosound Alpha 6 Diagnostic Ultrasound System | 2009 |
| † | K040719 | Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 49 ancestors have a recall of any class.
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. 2018, 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 ProVu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181124: Acessa ProVu System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181124
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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