510(k) · Cleared
ClearedSurx RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surx, Inc. · MUK Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Cleared on May 30, 2002 as substantially equivalent to K011190 (Surx, Inc., 2002) and 1 other predicate after a 66-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- May 30, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- MUK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K943450 (1995). 30 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
- 1 generation backK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
- This deviceK020952 Surx RF SystemSurx, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −6 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP… | Surx, Inc. | 2002 | — |
| −1 | K020126 | Modification to Surx Radiofrequency Electrosurgical Generator System and… | Surx, Inc. | 2002 | — |
| 0 (this device) | K020952 | Surx RF System | Surx, Inc. | 2002 | — |
| +1 | K042132 | Novasys Transurethral RF System | Novasys Medical, Inc. | 2004 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 MUK? 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? (2)
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 |
|---|---|---|---|
| * | K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Summary page 1…agulation Device and Accessories (21 CFR 878.4400) Device Panel: General Surgery/Restorative Devices Device Classification: Class II PREDICATE DEVICES o SURx LP System (K011190) ¢ SURx TV System (K020126) DEVICE DESCRIPTION The SURx RF System consists of two components: the SURx Radiofrequency (RF) Gene… | 2002 |
| * | K020126 | Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Summary page 1…ories (21 CFR 878.4400) Device Panel: General Surgery/Restorative Devices Device Classification: Class II PREDICATE DEVICES o SURx LP System (K011190) ¢ SURx TV System (K020126) DEVICE DESCRIPTION The SURx RF System consists of two components: the SURx Radiofrequency (RF) Generator and the SURx Applicat… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042132 | Novasys Transurethral RF System | 2004 | 0 |
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 7 years and passes through 2 companies; a new generation was cleared every 3 months on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K042132 (Novasys Medical, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K011190.
How does its category compare?
All MUK devicesMUK Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUK
FDA has decided no MUK device since 2007.
Median 510(k) review, days · MUK
Too few MUK 510(k)s in any year since 2007 to give a median.
Recalls per year · MUK
No recall names MUK since 2007.
Adverse event reports per year · MUK
1in 2007
MAUDE reports naming product code MUK, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020952: Surx RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020952
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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