510(k) · Cleared
Recalled · 2009Novasys Transurethral RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novasys Medical, Inc. · NVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Cleared on Dec 21, 2004 as substantially equivalent to K001150 (Novasys Medical, Inc., 2000) and 2 other predicates after a 134-day review. Its family tree reaches back 8 generations to 1995. It has been recalled once.
- Decided
- Dec 21, 2004
- Review
- 134 days
- Class
- Class II
- Product code
- NVJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K943450 (1995). 33 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
- 2 generations backK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
- 1 generation backK020952 Surx RF SystemSurx, Inc. · 2002
- This deviceK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP… | Surx, Inc. | 2002 | — |
| −2 | K020126 | Modification to Surx Radiofrequency Electrosurgical Generator System and… | Surx, Inc. | 2002 | — |
| −1 | K020952 | Surx RF System | Surx, Inc. | 2002 | — |
| 0 (this device) | K042132 | Novasys Transurethral RF System | Novasys Medical, Inc. | 2004 | — |
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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NVJ? 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 |
|---|---|---|---|
| * | K001150 | Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle…Summary page 6…S L APt e WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 1. Technological Characteristics Predicate Devices o Novasys Electrosurgical Electrode Family Novasys Medical, Inc. K001150 e Novasys “Ariel” RF Electrosurgical Control Module and Accessories Novasys Medical, Inc. K013730 2. Indication for Use Statemen… | 2000 |
| * | K013730 | Ariel Radio Frequency (RF) Electrosurgical Control Module and AccessoriesSummary page 6…vices o Novasys Electrosurgical Electrode Family Novasys Medical, Inc. K001150 e Novasys “Ariel” RF Electrosurgical Control Module and Accessories Novasys Medical, Inc. K013730 2. Indication for Use Statement Predicate Device e SURx RF System SURX, Inc. K020952 DEVICE DESCRIPTION The Novasys Transureth… | 2002 |
| * | K020952 | Surx RF SystemSummary page 6…ys “Ariel” RF Electrosurgical Control Module and Accessories Novasys Medical, Inc. K013730 2. Indication for Use Statement Predicate Device e SURx RF System SURX, Inc. K020952 DEVICE DESCRIPTION The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novas… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2009 | Not classified | Z-1404-2010 | Labeling design | Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 2 of the 33 ancestors have a recall of any class.
How does its category compare?
All NVJ devicesNVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVJ
FDA has decided no NVJ device since 2007.
Median 510(k) review, days · NVJ
Too few NVJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NVJ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVJ
2in 2014
MAUDE reports naming product code NVJ, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 1 | 82 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 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 Novasys Transurethral RF System is indicated for the transurethral treatment
of female stress urinary incontinence due to hypermobility in women who have
failed conservative treatment and who are not candidates for surgical therapy.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042132: Novasys Transurethral RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042132
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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