510(k) Report

510(k) · Cleared

Cleared

Cool-Tip Switching Controller, CTSW Control

K070446510(k) TraditionalCleared May 2, 200776-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

Valleylab,A Division of Tyco Healthcare Group LP · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 2, 2007 as substantially equivalent to K973297 (Radionics, Inc., 1997) and 4 other predicates after a 76-day review. Its family tree reaches back 6 generations to 1987. 2 later devices descend from it.

Decided
May 2, 2007
Review
76 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K870028 (1987). 19 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1999: 3 other ancestors1997: 2 other ancestors2003: 2 other ancestors2001: 2 other ancestors2000: 2 other ancestors1998: 1 other ancestor2022: 1 descendant cleared2020: 1 descendant clearedK870028 · 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 · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors 1 generation forward: 2 descendants 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 deviceK070446 Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP · 2007
  8. Descendant · cites it directly · 0 of its ownK203150 Cool-tip RF Ablation System E SeriesCovidien, LLC · 2022
  9. Descendant · cites it directly · 0 of its ownK192715 CRF Radiofrequency Ablation SystemCambridge Interventional, LLC · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K203150Cool-tip RF Ablation System E SeriesCovidien, LLC · 2022 · cites it directly0descendants
  • K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC · 2020 · cites it directly0descendants
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)K070446Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP2007—
+1K203150Cool-tip RF Ablation System E SeriesCovidien, LLC2022—
+1K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
199930
200020
200120
200320
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202210
FIG. 1 — Lineage of K070446, 1987–2022Source: 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 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
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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
*K973297Cosman Coagulator (CC-1) System
Summary page 1
…the Cool-tipTM Switching Controller is identical to that of the Cool- tipTM RF System. The Cool-tip TM RF System received initial FDA clearance in 510(k)s K973297 (10/29/97) and K984552 (3/5/99). Additional clearance with the Cool-tip TM RF System was obtained for specific claims unde…
Radionics, Inc.19971
*K984552Cool-Tip RF System
Summary page 1
…ng Controller is identical to that of the Cool- tipTM RF System. The Cool-tip TM RF System received initial FDA clearance in 510(k)s K973297 (10/29/97) and K984552 (3/5/99). Additional clearance with the Cool-tip TM RF System was obtained for specific claims under 510(k)s K042216 (Live…
Radionics, Inc.19991
*K042216Cool-Tip RF Ablation System
Summary page 1
…ance in 510(k)s K973297 (10/29/97) and K984552 (3/5/99). Additional clearance with the Cool-tip TM RF System was obtained for specific claims under 510(k)s K042216 (Liver lesions, 11/12/04), K052796 (Osteoid Osteoma claim, 2/3/06) and K053290 (Liver tumor claim, 3/15/06). 4.…
Valleylab2004—
*K052796Cool-Tip RF Generator, Cool-Tip RF System Accessories
Summary page 1
…and K984552 (3/5/99). Additional clearance with the Cool-tip TM RF System was obtained for specific claims under 510(k)s K042216 (Liver lesions, 11/12/04), K052796 (Osteoid Osteoma claim, 2/3/06) and K053290 (Liver tumor claim, 3/15/06). 4. Device Description The Cool-tipT…
Valleylab2006—
*K053290Cool-Tip RF Generator, Cool-Tip RF System Accessories
Summary page 1
…ith the Cool-tip TM RF System was obtained for specific claims under 510(k)s K042216 (Liver lesions, 11/12/04), K052796 (Osteoid Osteoma claim, 2/3/06) and K053290 (Liver tumor claim, 3/15/06). 4. Device Description The Cool-tipTM Switching Controller (CTSW Control) is an…
Valleylab2006—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K203150Cool-tip RF Ablation System E SeriesCovidien, LLC20220
K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC20200

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 20 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 5 of the 19 ancestors have a recall of any class.
  • Of its descendants, K203150 (Covidien, LLC, 2022) has gone furthest, with 0 descendants of its own.

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. 2007, 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 Cool-tipTM RF Switching Controller is to be used with the Cool-tipTM RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

Indications for use as stated in the FDA summary.

More from Valleylab,A Division of Tyco…

2 FDA decisions under this applicant name. See the company

  • K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007

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https://510kreport.com/device/K070446 · printed Nov 3, 2026

Cite this page

510(k) Report. “K070446: Cool-Tip Switching Controller, CTSW Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070446

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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