510(k) Report

510(k) · Cleared

Cleared

Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007

K003978510(k) TraditionalCleared May 22, 2001151-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

Afx, Inc. · NEY System, Ablation, Microwave And Accessories

Cleared on May 22, 2001 after a 151-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 414 devices in its family, counting itself, has a Class I recall. 413 later devices descend from it.

Decided
May 22, 2001
Review
151 days
Class
Class II
Product code
NEY
Recalls
None
Predicates
0

413 later devices descend from it, 12 citing it directly. 1 of the 414 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 7 descendants cleared2008: 17 descendants cleared2002: 3 descendants cleared2007: 7 descendants cleared2006: 18 descendants cleared2003: 3 descendants cleared2005: 6 descendants cleared2011: 10 descendants cleared2010: 5 descendants cleared2009: 10 descendants cleared2018: 26 descendants cleared2012: 13 descendants cleared2014: 17 descendants cleared2016: 16 descendants cleared2019: 20 descendants cleared2013: 11 descendants cleared2024: 35 descendants cleared2017: 18 descendants cleared2021: 22 descendants cleared2022: 22 descendants cleared2023: 27 descendants cleared, 1 with a Class I recall12025: 35 descendants cleared2020: 27 descendants cleared2015: 9 descendants cleared2026: 29 descendants cleared200020052010201520202025
  1. This deviceK003978 Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand…Afx, Inc. · 2001
  2. Descendant · cites it directly · 340 of its ownK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
  3. Descendant · cites it directly · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
  4. Descendant · 2 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  5. Descendant · 3 generations on · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  6. Descendant · 3 generations on · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled

Showing 5 of 413 descendants. See all descendants

Descendants cleared per year

2002: 32003: 32004: 72005: 62006: 182007: 72008: 172009: 102010: 52011: 102012: 132013: 112014: 172015: 92016: 162017: 182018: 262019: 202020: 272021: 222022: 222023: 272024: 352025: 352026: 29
2002high 35 (2024) · low 3 (2002)2026

Class I recalls in this family

  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 413 · See all
  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002 · cites it directly340descendants
  • K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · cites it directly268descendants
  • K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 2 generations on251descendants
  • K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · 3 generations on231descendants
  • K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · 3 generations on230descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003978Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series…Afx, Inc.2001—
+1K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002—
+1K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004—
+2K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
+3K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
+3K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200551

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200330
200470
200560
2006180
200770
2008170
2009100
201050
2011100
2012130
2013110
2014170
201590
2016160
2017180
2018260
2019200
2020270
2021220
2022220
2023271
2024350
2025350
2026290
FIG. 1 — Lineage of K003978, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 NEY device

  1. #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (413)

See all 413

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

NumberDeviceApplicantDecidedDescendants
K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002340
K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004268
K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular2002102
K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp200261
K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.200741
K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423
K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422
K043579Atricure Bipolar SystemAtriCure, Inc.200718
K073605Atricure Coolrail Linear PenAtriCure, Inc.200813
K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K013946 (Afx, Inc., 2002) has gone furthest, with 340 descendants of its own.

How does its category compare?

All NEY devices

NEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEY

1in 2025

2007: 22008: 32009: 42010: 32012: 32013: 12014: 12015: 22016: 32017: 32018: 32019: 22020: 72021: 42022: 12023: 92024: 72025: 12026 (partial year): 2
2007high 9 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEY

94in 2024

2008: 145 days median2009: 169 days median2010: 219 days median2012: 81 days median2016: 30 days median2017: 121 days median2018: 90 days median2020: 178 days median2021: 379 days median2023: 155 days median2024: 94 days median
2007high 379 (2021) · low 30 (2016)2026

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

Recalls per year · NEY

1in 2022

2017: 122018: 32021: 12022: 1
2007high 12 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NEY

112in 2025

2007: 182008: 152009: 72010: 282011: 262012: 92013: 162014: 272015: 922016: 1762017: 2252018: 1022019: 1232020: 1282021: 2172022: 1422023: 1062024: 1412025: 112
2007high 225 (2017) · low 7 (2009)2025

MAUDE reports naming product code NEY, 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
20072—018
20083145015
2009416907
20103219028
20110—026
201238109
20131—016
20141—027
20152—092
20163300176
2017312112225
20183903102
20192—0123
202071780128
202143791217
20221—1142
202391550106
20247940141
20251—0112
20262—0—

More from Afx, Inc.

2 FDA decisions under this applicant name. See the company

  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002

Recent decisions in NEY

The NEY category page

  • K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd. · 2026
  • K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6…Nanjing Devin Medical Technology Co., Ltd. · 2026
  • K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited · 2025
  • K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc. · 2024
  • K241825Microwave Ablation AntennasCanyon Medical, Inc. · 2024

https://510kreport.com/device/K003978 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003978

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026