510(k) Report

510(k) · Cleared

Cleared

Bovie J-Plasma Handpiece with Retractable Cutting Blade

K112233510(k) TraditionalCleared Jan 27, 2012176-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 Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 27, 2012 as substantially equivalent to K090586 (Bovie Medical, 2009) after a 176-day review. Its family tree reaches back 4 generations to 1989. 14 later devices descend from it.

Decided
Jan 27, 2012
Review
176 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K894762 (1989). 8 ancestors in all, the oldest K871435 (1987). 14 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 ancestor2015: 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. · 2004K090586 · Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC) · Bovie Medical · 20091990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K090586 · Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC) · Bovie Medical · 2009K030819 · 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 · 4 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 3 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. 2 generations backK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
  4. 1 generation backK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
  5. This deviceK112233 Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012
  6. Descendant · cites it directly · 13 of its ownK151325 Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · Recalled
  7. Descendant · 2 generations on · 12 of its ownK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
  8. Descendant · cites it directly · 11 of its ownK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
  9. Descendant · 2 generations on · 6 of its ownK183610 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open…Bovie Medical Corporation · 2019 · Recalled
  10. Descendant · 2 generations on · 4 of its ownK191542 Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation · 2019

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015: 22017: 22019: 42021: 12022: 22023: 3
2015high 4 (2019) · low 0 (2016)2026

Most influential descendants

Showing 5 of 14 · See all
  • K151325Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · cites it directly13descendants
  • K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · 2 generations on12descendants
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation · 2017 · cites it directly11descendants
  • K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation · 2019 · 2 generations on6descendants
  • K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation · 2019 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−3K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
−2K030819Plasmajet SystemPlasma Surgical, Ltd.2004—
−1K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable…Bovie Medical2009—
0 (this device)K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation2012—
+1K151325Bovie J-Plasma HandpieceBovie Medical Corporation20151
+2K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation20155
+1K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation20176
+2K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open…Bovie Medical Corporation20191
+2K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199020
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201720
201940
202110
202220
202330
FIG. 1 — Lineage of K112233, 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? (1)

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
*K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…
Summary page 1
…2l1CFR 878.4400; Class HI; Product Code GEl Legally Marketed Predicate Device(s): Bavie ICON GS Electrosurgical Handpiece (K0905 86) Included Accessories: J-Plasma Handpiece with Bovle ICON GS Electro…
Bovie Medical2009—

Also cleared against K090586: 1 other device →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K151325Bovie J-Plasma HandpieceBovie Medical Corporation201513
K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation201711

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 23 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K151325 (Bovie Medical Corporation, 2015) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K090586.

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 Bovie® J-Plasrna Handpiece with Retractable Cutting Blade is an electrosurgical dev'ice that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K090586

1 other device cites the same predicate.

  • K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014

More from Bovie Medical Corporation

14 FDA decisions under this applicant name. See the company

  • K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise…Bovie Medical Corporation · 20191 recall
  • K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorBovie Medical Corporation · 20176 recalls
  • K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar…Bovie Medical Corporation · 20163 recalls
  • K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942…Bovie Medical Corporation · 2016

Recent decisions in GEI

The GEI category page

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https://510kreport.com/device/K112233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112233: Bovie J-Plasma Handpiece with Retractable Cutting Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112233

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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