510(k) Report

510(k) · Cleared

Cleared

Bissinger Monopolar Forceps and Cables

K143662510(k) TraditionalCleared Mar 12, 201579-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

Medagent, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 12, 2015 as substantially equivalent to K101080 (Egon Faulhaber Surgical Instruments Pinzetten, 2010) and 3 other predicates after a 79-day review. Its family tree reaches back 6 generations to 1999.

Decided
Mar 12, 2015
Review
79 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K991218 (1999). 23 ancestors in all, the oldest K896450 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2008: 2 other ancestors2004: 3 other ancestors1994: 2 other ancestors2000: 3 other ancestors2006: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor1991: 1 other ancestor2001: 1 other ancestorK991218 · Oratec Bipolar Ablation Probes · Oratec Interventions, Inc. · 1999K031371 · Saphyre Bipolar Ablation Probes · Smith & Nephew, Inc. · 2003K043442 · Stryker RF Coaxial Bipolar Electrodes & Cannulae · Stryker Instruments · 2005K061660 · Stryker RF Parallel Bipolar Adaptor Cable · Stryker Instruments · 2006K083528 · Smith & Nephew Bipolar Adapter Cable, Model 72200022 · Smith & Nephew, Inc. · 2009K111262 · Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop · Olsen Medical · 2012 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 4 other ancestors5 generations back: 4 other ancestors6 generations back: 2 other ancestors K111262 · Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop · Olsen Medical · 2012 · recalledK083528 · Smith & Nephew Bipolar Adapter Cable, Model 72200022 · Smith & Nephew, Inc. · 2009K061660 · Stryker RF Parallel Bipolar Adaptor Cable · Stryker Instruments · 2006K043442 · Stryker RF Coaxial Bipolar Electrodes & Cannulae · Stryker Instruments · 2005K031371 · Saphyre Bipolar Ablation Probes · Smith & Nephew, Inc. · 2003K991218 · Oratec Bipolar Ablation Probes · Oratec Interventions, Inc. · 1999−50
  1. Root · 6 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
  2. 5 generations backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
  3. 4 generations backK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
  4. 3 generations backK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
  5. 2 generations backK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
  6. 1 generation backK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
  7. This deviceK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K991218Oratec Bipolar Ablation ProbesOratec Interventions, Inc.1999—
−5K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc.2003—
−4K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments2005—
−3K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments2006—
−2K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc.2009—
−1K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/…Olsen Medical20122
0 (this device)K143662Bissinger Monopolar Forceps and CablesMedagent, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420
200030
200110
200210
200310
200430
200510
200610
200820
201010
FIG. 1 — Lineage of K143662, 1999–2015Source: 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? (4)

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
*K101080Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps…
Summary page 5
…A: Predicate Device 510(k) Number 510(k) Holder EGON FAULHABER Bipolar Forceps, Non K101080 EGON FAULHABER Surgical Instruments Pinzetten Stick Bipolar Forceps and Monopolar For- ceps Black…
Egon Faulhaber Surgical Instruments Pinzetten2010—
*K072124Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes
Summary page 5
…EGON FAULHABER Surgical Instruments Pinzetten Stick Bipolar Forceps and Monopolar For- ceps Black and Black Electrosurgical Cutting and K072124 Black & Black surgical Inc. Coagulation Forceps and Electrodes Olsen Medical Electrosurgical Ca-…
Black & Black Surgical, Inc.2008—
*K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…
Summary page 5
…d K072124 Black & Black surgical Inc. Coagulation Forceps and Electrodes Olsen Medical Electrosurgical Ca- K111262 Olsen Medical ble/Adapters Suffer Electrosurgical Cables K…
Olsen Medical20122
*K073450Sutter Electrosurgical Cables
Summary page 5
…trosurgical Ca- K111262 Olsen Medical ble/Adapters Suffer Electrosurgical Cables K073450 Suffer Medizintechnik GmbH 001_510K_Summary_v.4…
Sutter Medizintechnik GmbH2008—

Also cleared against K101080: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 5 companies; a new generation was cleared every 2.8 years on median.
  • 4 of the 23 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K101080.

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. 2015, 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 monopolar forceps and clamps are designed to grasp, dissect and coagulate tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation.

Do not exceed a maximum output of 2000 Vp of your generator.

Indications for use as stated in the FDA summary.

Also cleared against K101080

2 other devices cite the same predicate.

  • K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use…Faulhaber Pinzetten Ohg · 2019
  • K131012Sutter Bipolar Forceps - SuperglissSutter Medizintechnik GmbH · 2013

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/K143662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143662: Bissinger Monopolar Forceps and Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143662

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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