510(k) Report

510(k) · Cleared

Cleared

Canady Plasma Probes

K052035510(k) TraditionalCleared Aug 31, 200534-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

Canady Technology, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 31, 2005 as substantially equivalent to K963189 (Erbe USA, Inc., 1996) and 2 other predicates after a 34-day review. Its family tree reaches back 3 generations to 1989. 6 later devices descend from it.

Decided
Aug 31, 2005
Review
34 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K894762 (1989). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1990: 1 other ancestor2008: 1 descendant cleared2011: 1 descendant cleared2022: 1 descendant cleared2013: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant clearedK894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 1989K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K013348 · Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 · Erbe USA, Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K013348 · Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 · Erbe USA, Inc. · 2001K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 19890
  1. Root · 3 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 2 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. 1 generation backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. This deviceK052035 Canady Plasma ProbesCanady Technology, LLC · 2005
  5. Descendant · cites it directly · 2 of its ownK100669 Canady Plasma Electrosurgical Unit Series with Accessory Probes and…Us Medical Innovations, LLC · 2011
  6. Descendant · cites it directly · 2 of its ownK081644 Beamer Argon ProbeConmed Corporation · 2008
  7. Descendant · 2 generations on · 1 of its ownK192124 Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019
  8. Descendant · 3 generations on · 0 of its ownK240297 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024
  9. Descendant · 2 generations on · 0 of its ownK221945 Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer…Conmed Corporation · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12013: 12019: 12022: 12024: 1
2008high 1 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 2011 · cites it directly2descendants
  • K081644Beamer Argon ProbeConmed Corporation · 2008 · cites it directly2descendants
  • K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019 · 2 generations on1descendant
  • K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024 · 3 generations on0descendants
  • K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED…Conmed Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−2K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
−1K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158…Erbe USA, Inc.2001—
0 (this device)K052035Canady Plasma ProbesCanady Technology, LLC2005—
+1K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC2011—
+1K081644Beamer Argon ProbeConmed Corporation2008—
+2K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC2019—
+3K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC2024—
+2K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER…Conmed Corporation2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201310
201910
202210
202410
FIG. 1 — Lineage of K052035, 1989–2024Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…
Summary page 1
…ion device and accessories (21CFR878.4400) Product Code: 79 GEl Predicate Devices: - Erbe APC Applicators: K#963189, cleared Nov. 26, 1996 - Erbe APC Applicators: K#013348, cleared Oct. 26, 2001…
Erbe USA, Inc.1996—
*K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…
Summary page 1
…e: 79 GEl Predicate Devices: - Erbe APC Applicators: K#963189, cleared Nov. 26, 1996 - Erbe APC Applicators: K#013348, cleared Oct. 26, 2001 - Conmed ABC Flex Probes: K# 990586, cleared May 17, 1999 Device Descripti…
Erbe USA, Inc.2001—
*K990586Conmed Abc Probe for Flexible Endoscopes
Summary page 1
…9, cleared Nov. 26, 1996 - Erbe APC Applicators: K#013348, cleared Oct. 26, 2001 - Conmed ABC Flex Probes: K# 990586, cleared May 17, 1999 Device Description: The Canady Plasma Probes are tubular instruments and are flexible. They are provided…
Conmedcorp1999—

Also cleared against K963189: 9 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112
K081644Beamer Argon ProbeConmed Corporation20082

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 16 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K100669 (Us Medical Innovations, LLC, 2011) has gone furthest, with 2 descendants of its own.
  • 9 other devices also cite its predicate K963189.

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.

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?

Argon Enhanced Coagulation of Tissue

Indications for use as stated in the FDA summary.

Also cleared against K963189

9 other devices cite the same predicate.

  • K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012
  • K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
  • K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc. · 2006
  • K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
  • K042274PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd. · 2005
  • K030819Plasmajet SystemPlasma Surgical, Ltd. · 2004

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K052035 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052035: Canady Plasma Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052035

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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