510(k) Report

510(k) · Cleared

Cleared

Serf Ablation System Serf Ablation Needle

K120116510(k) TraditionalCleared Oct 1, 2012262-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

Thermedical · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 1, 2012 as substantially equivalent to K993944 (Rita Medical Systems, 1999) and 4 other predicates after a 262-day review. Its family tree reaches back 6 generations to 1987.

Decided
Oct 1, 2012
Review
262 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K870028 (1987). 18 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor1999: 3 other ancestors2001: 2 other ancestors2000: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor2003: 2 other ancestorsK870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 1987K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K021329 · Rita System · Rita Medical Systems · 2002K042216 · Cool-Tip RF Ablation System · Valleylab · 2004K052796 · Cool-Tip RF Generator, Cool-Tip RF System Accessories · Valleylab · 2006198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors K052796 · Cool-Tip RF Generator, Cool-Tip RF System Accessories · Valleylab · 2006K042216 · Cool-Tip RF Ablation System · Valleylab · 2004K021329 · Rita System · Rita Medical Systems · 2002K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 1987−50
  1. Root · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. 3 generations backK021329 Rita SystemRita Medical Systems · 2002
  5. 2 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
  6. 1 generation backK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
  7. This deviceK120116 Serf Ablation System Serf Ablation NeedleThermedical · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−5K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−4K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
−3K021329Rita SystemRita Medical Systems2002—
−2K042216Cool-Tip RF Ablation SystemValleylab2004—
−1K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab2006—
0 (this device)K120116Serf Ablation System Serf Ablation NeedleThermedical2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199930
200020
200120
200320
200610
FIG. 1 — Lineage of K120116, 1987–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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
*K993944Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive…
Summary page 1
…AngioDynamnics / RITA Model 1500 Electrosurgical RF Generator - Class 11 - 2 1CFR878.4400, which has been the subject of a cleared 5 10(k) with FDA log number K993944, K02 1329 and others. * Covidien / ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories - Class 11 - 21CFR87…
Rita Medical Systems1999—
*K021329Rita System
Summary page 1
…ynamnics / RITA Model 1500 Electrosurgical RF Generator - Class 11 - 2 1CFR878.4400, which has been the subject of a cleared 5 10(k) with FDA log number K993944, K02 1329 and others. * Covidien / ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories - Class 11 - 21CFR878.4400, wh…
Rita Medical Systems2002—
*K984552Cool-Tip RF System
Summary page 1
…lleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories - Class 11 - 21CFR878.4400, which has been the subject of a cleared 5 10(k) with FDA log number K984552, K052796 and K053290. Technological Characteristics The SERF Ablation System and SERF Ablation Needle provide heat to unwanted ti…
Radionics, Inc.19991
*K052796Cool-Tip RF Generator, Cool-Tip RF System Accessories
Summary page 1
…ool-Tip RF Generator, Cool-Tip RF System and Accessories - Class 11 - 21CFR878.4400, which has been the subject of a cleared 5 10(k) with FDA log number K984552, K052796 and K053290. Technological Characteristics The SERF Ablation System and SERF Ablation Needle provide heat to unwanted tissue targ…
Valleylab2006—
*K053290Cool-Tip RF Generator, Cool-Tip RF System Accessories
Summary page 1
…enerator, Cool-Tip RF System and Accessories - Class 11 - 21CFR878.4400, which has been the subject of a cleared 5 10(k) with FDA log number K984552, K052796 and K053290. Technological Characteristics The SERF Ablation System and SERF Ablation Needle provide heat to unwanted tissue targeted for abl…
Valleylab2006—

Also cleared against K993944: 5 other devices →

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 4 companies; a new generation was cleared every 4.6 years on median.
  • 4 of the 18 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K993944.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The SERF Ablation System is intended for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K993944

5 other devices cite the same predicate.

  • K094009Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 2010
  • K042096Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc. · 2006
  • K042216Cool-Tip RF Ablation SystemValleylab · 2004
  • K021329Rita SystemRita Medical Systems · 2002
  • K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K120116 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120116: Serf Ablation System Serf Ablation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120116

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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