510(k) Report

510(k) · Cleared

Cleared

Bovie Hand Control

K790187510(k) TraditionalCleared Feb 27, 197929-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

Sybron Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 27, 1979 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided
Feb 27, 1979
Review
29 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

66 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2001: 3 descendants cleared2002: 4 descendants cleared2003: 3 descendants cleared2007: 3 descendants cleared2004: 1 descendant cleared2006: 2 descendants cleared2005: 1 descendant cleared2008: 2 descendants cleared2015: 8 descendants cleared2009: 3 descendants cleared2016: 6 descendants cleared2010: 2 descendants cleared2023: 2 descendants cleared2018: 3 descendants cleared2014: 1 descendant cleared2019: 3 descendants cleared2011: 1 descendant cleared2025: 2 descendants cleared2024: 4 descendants cleared2013: 1 descendant cleared2026: 1 descendant cleared2017: 5 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 2 descendants cleared19801990200020102020
  1. This deviceK790187 Bovie Hand ControlSybron Corp. · 1979
  2. Descendant · cites it directly · 31 of its ownK012023 Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF…Senorx, Inc. · 2001
  3. Descendant · 2 generations on · 29 of its ownK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 28 of its ownK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
  5. Descendant · cites it directly · 28 of its ownK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  6. Descendant · 3 generations on · 27 of its ownK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2001: 32002: 42003: 32004: 12005: 12006: 22007: 32008: 22009: 32010: 22011: 12013: 12014: 12015: 82016: 62017: 52018: 32019: 32020: 22021: 12022: 22023: 22024: 42025: 22026: 1
2001high 8 (2015) · low 0 (2012)2026

Most influential descendants

Showing 5 of 66 · See all
  • K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc. · 2001 · cites it directly31descendants
  • K022314Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · 2 generations on29descendants
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005 · 3 generations on28descendants
  • K023311Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003 · cites it directly28descendants
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006 · 3 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K790187Bovie Hand ControlSybron Corp.1979—
+1K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc.2001—
+2K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.20021
+3K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc.2005—
+1K023311Loop Microwave Ablation ProbeVivant Medical, Inc.2003—
+3K061510Sanarus Visica Treatment SystemSanarus Medical, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200130
200240
200330
200410
200510
200620
200730
200820
200930
201020
201110
201310
201410
201580
201660
201750
201830
201930
202020
202110
202220
202320
202440
202520
202610
FIG. 1 — Lineage of K790187, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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?

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

What descends from it? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc.200131
K023311Loop Microwave Ablation ProbeVivant Medical, Inc.200328
K012004Easy Guide Electrosurgical Access DeviceSenorx, Inc.20012
K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc.20012
K022286Encircle Localization DeviceVivant Medical, Inc.20020

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?

  • Of its descendants, K012023 (Senorx, Inc., 2001) has gone furthest, with 31 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.

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—

More from Sybron Corp.

37 FDA decisions under this applicant name. See the company

  • K862284SealiteSybron Corp. · 1986
  • K854855Proof Alginate Impression MaterialSybron Corp. · 1986
  • K844092Diagnostic Microsopce SlidesSybron Corp. · 1984
  • K842132Tycos Self-Check/Digital Fever ThermoSybron Corp. · 1984
  • K841910Kerr Sealapex Root Canal SealerSybron Corp. · 1984

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K790187 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790187: Bovie Hand Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790187

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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