510(k) Report

510(k) · Cleared

Cleared

Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)

K011190510(k) TraditionalCleared Jan 8, 2002264-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Surx, Inc. · MUK Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Cleared on Jan 8, 2002 as substantially equivalent to K960918 (Vidamed, Inc., 1996) and 8 other predicates after a 264-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.

Decided
Jan 8, 2002
Review
264 days
Class
Class II
Product code
MUK
Recalls
None
Predicates
9

Its longest line of descent runs back 5 generations to K943450 (1995). 28 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 5 other ancestors1996: 7 other ancestors1995: 4 other ancestors1994: 2 other ancestors1991: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1989: 1 other ancestor2002: 2 descendants cleared2004: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 12 other ancestors3 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−50
  1. Root · 5 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 4 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 3 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 2 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 1 generation backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. This deviceK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
  7. Descendant · cites it directly · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
  8. Descendant · cites it directly · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
  9. Descendant · 2 generations on · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · cites it directly2descendants
  • K020952Surx RF SystemSurx, Inc. · 2002 · cites it directly1descendant
  • K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−4K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−3K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−2K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−1K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
0 (this device)K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP…Surx, Inc.2002—
+1K020126Modification to Surx Radiofrequency Electrosurgical Generator System and…Surx, Inc.2002—
+1K020952Surx RF SystemSurx, Inc.2002—
+2K042132Novasys Transurethral RF SystemNovasys Medical, Inc.20041

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198910
199110
199420
199540
199670
199750
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
FIG. 1 — Lineage of K011190, 1995–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K960918Vidamed Tuna (Transurethral Needle Ablation) System
Summary page 1
…Class II PREDICATE DEVICES Predicate Radiofreauency Electrosurgical Generator Systems " Vidamed TUNA® (Transurethral Needle Ablation) System (K960918, K965199, K002583) " ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventio…
Vidamed, Inc.1996—
*K965199Tuna 5 Catheter
Summary page 1
…DICATE DEVICES Predicate Radiofreauency Electrosurgical Generator Systems " Vidamed TUNA® (Transurethral Needle Ablation) System (K960918, K965199, K002583) " ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventions Model ORA 40 E…
Vidamed, Inc.1997—
*K002583Tuna (Trans Urethra Needle) Office System
Summary page 1
…DEVICES Predicate Radiofreauency Electrosurgical Generator Systems " Vidamed TUNA® (Transurethral Needle Ablation) System (K960918, K965199, K002583) " ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventions Model ORA 40 Electrothe…
Vidamed, Inc.2001—
*K961069Arthrocare Urologic Multi-Electrode Electrosurgery System
Summary page 1
…tems " Vidamed TUNA® (Transurethral Needle Ablation) System (K960918, K965199, K002583) " ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventions Model ORA 40 Electrothermal Generator (K973159, K964071, K971532) Predicate Indicatio…
Arthrocare Corp.1996—
*K973159Oratec Interventions Model Ora 40 Electrothermal Generator
Summary page 1
…K965199, K002583) " ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventions Model ORA 40 Electrothermal Generator (K973159, K964071, K971532) Predicate Indications for Use Devices " Louisville Laboratories, Laparoscopic Bladder Nec…
Oratec Interventions, Inc.1997—
*K964071Oratec Interventions Model Ora 50 Electrothermal Generator
Summary page 1
…K002583) " ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventions Model ORA 40 Electrothermal Generator (K973159, K964071, K971532) Predicate Indications for Use Devices " Louisville Laboratories, Laparoscopic Bladder Neck Suspension Kit…
Oratec Interventions, Inc.1996—
*K971532Arthrocare Electrosurgery System
Summary page 1
…" ArthroCare Urologic Multi-Electrode Electrosurgery System (K961069) " Oratec Interventions Model ORA 40 Electrothermal Generator (K973159, K964071, K971532) Predicate Indications for Use Devices " Louisville Laboratories, Laparoscopic Bladder Neck Suspension Kit (…
Arthrocare Corp.1997—
*K971797Laparoscopic Bladder Neck Suspension Kit
Summary page 1
…rator (K973159, K964071, K971532) Predicate Indications for Use Devices " Louisville Laboratories, Laparoscopic Bladder Neck Suspension Kit (K971797) " Empi, Inc. Innova® ComfortPulse® Vaginal Electrode (K964577) 1 === Page…
Louisville Laboratories, Inc.1997—
*K964577Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal…
Summary page 1
…for Use Devices " Louisville Laboratories, Laparoscopic Bladder Neck Suspension Kit (K971797) " Empi, Inc. Innova® ComfortPulse® Vaginal Electrode (K964577) 1 SURx Women's Health First 1<0…
Empi1997—

Also cleared against K960918: 4 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022
K020952Surx RF SystemSurx, Inc.20021

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 8 months on median.
  • 2 of the 28 ancestors have a recall of any class.
  • Of its descendants, K020126 (Surx, Inc., 2002) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K960918.

How does its category compare?

All MUK devices

MUK 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

2007: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code MUK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The SURx Laparoscopic Probe (LP) Radio Frequency (RF) System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

Indications for use as stated in the FDA summary.

Also cleared against K960918

4 other devices cite the same predicate.

  • K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 20051 recall
  • K991847Thermoflex SystemArgomed, Inc. · 1999
  • K965199Tuna 5 CatheterVidamed, Inc. · 1997
  • K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997

More from Surx, Inc.

3 FDA decisions under this applicant name. See the company

  • K020952Surx RF SystemSurx, Inc. · 2002
  • K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System)Surx, Inc. · 2002

Recent decisions in MUK

The MUK category page

  • K020952Surx RF SystemSurx, Inc. · 2002
  • K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System)Surx, Inc. · 2002

https://510kreport.com/device/K011190 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011190

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026