510(k) Report

510(k) · Cleared

Cleared

Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC)

K090586510(k) TraditionalCleared Aug 7, 2009156-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

Bovie Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 7, 2009 as substantially equivalent to K972267 (Tenerco, Inc., 1999) and 1 other predicate after a 156-day review. Its family tree reaches back 3 generations to 1989. 16 later devices descend from it.

Decided
Aug 7, 2009
Review
156 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K894762 (1989). 7 ancestors in all, the oldest K871435 (1987). 16 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1990: 2 other ancestors1987: 1 other ancestor2014: 1 descendant cleared2012: 1 descendant cleared2015: 2 descendants cleared2017: 2 descendants cleared2019: 4 descendants cleared2021: 1 descendant cleared2022: 2 descendants cleared2023: 3 descendants clearedK894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 1989K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K030819 · Plasmajet System · Plasma Surgical, Ltd. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K030819 · Plasmajet System · Plasma Surgical, Ltd. · 2004K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 19890+5
  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 backK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
  4. This deviceK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
  5. Descendant · cites it directly · 14 of its ownK112233 Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012
  6. Descendant · 2 generations on · 13 of its ownK151325 Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · Recalled
  7. Descendant · 3 generations on · 12 of its ownK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
  8. Descendant · cites it directly · 12 of its ownK142975 Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014
  9. Descendant · 2 generations on · 11 of its ownK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 22017: 22019: 42021: 12022: 22023: 3
2012high 4 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 16 · See all
  • K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012 · cites it directly14descendants
  • K151325Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · 2 generations on13descendants
  • K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · 3 generations on12descendants
  • K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014 · cites it directly12descendants
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation · 2017 · 2 generations on11descendants
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—
−1K030819Plasmajet SystemPlasma Surgical, Ltd.2004—
0 (this device)K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable…Bovie Medical2009—
+1K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation2012—
+2K151325Bovie J-Plasma HandpieceBovie Medical Corporation20151
+3K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation20155
+1K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation2014—
+2K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation20176

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199020
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201520
201720
201940
202110
202220
202330
FIG. 1 — Lineage of K090586, 1989–2023Source: 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? (2)

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
*K972267Helica TC
Summary page 1
…surgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code GE[) Predicate Devices: Tenerco, Inc. Helica TC Thermo Coagulator (K972267) Plasma Surgical Ltd. PlasmaJet System (K030819) 5-2…
Tenerco, Inc.1999—
*K030819Plasmajet System
Summary page 1
…21CFR 878.4400; Class II; Product Code GE[) Predicate Devices: Tenerco, Inc. Helica TC Thermo Coagulator (K972267) Plasma Surgical Ltd. PlasmaJet System (K030819) 5-2 510(k) SUMMARY (As Required per 21 CFR 807…
Plasma Surgical, Ltd.2004—

Also cleared against K972267: 1 other device →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation201214
K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412

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 7.2 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K112233 (Bovie Medical Corporation, 2012) has gone furthest, with 14 descendants of its own.
  • 1 other device also cites its predicate K972267.

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. 2009, 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 Bovie ICON GS system is an electrosurgical device that utilizes Helium gas for the coagulation of soft tissues during open soft tissue surgery.

Indications for use as stated in the FDA summary.

Also cleared against K972267

1 other device cites the same predicate.

  • K032969Helica TC Laparoscopic Cutting and Cauterising (LTC) ProbeHelica Instruments, Ltd. · 2004

More from Bovie Medical

8 FDA decisions under this applicant name. See the company

  • K092149Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model BOSA1215Bovie Medical · 2010
  • K091440Laparoscopic Resection Device, Model SR326LBovie Medical · 2009
  • K082568Saline Enhanced Electrosurgical Resection (Seer) DeviceBovie Medical · 2008
  • K082109Bovie Icon General Purpose RF GeneratorBovie Medical · 2008
  • K081431Meg Laparoscopic ElectrodesBovie Medical · 2008

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The GEI category page

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https://510kreport.com/device/K090586 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090586

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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