510(k) Report

510(k) · Cleared

Cleared

Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories

K963189510(k) TraditionalCleared Nov 26, 1996104-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

Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 26, 1996 as substantially equivalent to K903724 (Beacon Laboratories, Inc., 1990) and 1 other predicate after a 104-day review. Its family tree reaches back 1 generation to 1989. 67 later devices descend from it.

Decided
Nov 26, 1996
Review
104 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K894762 (1989). 2 ancestors in all. 67 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor1999: 1 descendant cleared2005: 3 descendants cleared2004: 1 descendant cleared2012: 3 descendants cleared2001: 1 descendant cleared2003: 1 descendant cleared2008: 4 descendants cleared2006: 4 descendants cleared2011: 2 descendants cleared2022: 5 descendants cleared2019: 7 descendants cleared2018: 1 descendant cleared2009: 3 descendants cleared2007: 3 descendants cleared2025: 5 descendants cleared2024: 2 descendants cleared2015: 3 descendants cleared2014: 2 descendants cleared2021: 4 descendants cleared2013: 1 descendant cleared2017: 3 descendants cleared2023: 5 descendants cleared2020: 3 descendants clearedK894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 14 descendants3 generations forward: 16 descendants4 generations forward: 8 descendants5 generations forward: 13 descendants6 generations forward: 3 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 19890+5
  1. Root · 1 generation backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. This deviceK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. Descendant · cites it directly · 30 of its ownK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. Descendant · cites it directly · 25 of its ownK024047 Erbe Vio Apc with AccessoriesErbe USA, Inc. · 2003
  5. Descendant · cites it directly · 17 of its ownK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
  6. Descendant · 2 generations on · 16 of its ownK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
  7. Descendant · 2 generations on · 16 of its ownK060183 Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe…Erbe USA, Inc. · 2006

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12003: 12004: 12005: 32006: 42007: 32008: 42009: 32011: 22012: 32013: 12014: 22015: 32017: 32018: 12019: 72020: 32021: 42022: 52023: 52024: 22025: 5
1999high 7 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 67 · See all
  • K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…Erbe USA, Inc. · 2001 · cites it directly30descendants
  • K024047Erbe Vio Apc with AccessoriesErbe USA, Inc. · 2003 · cites it directly25descendants
  • K030819Plasmajet SystemPlasma Surgical, Ltd. · 2004 · cites it directly17descendants
  • K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…Bovie Medical · 2009 · 2 generations on16descendants
  • K060183Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterErbe USA, Inc. · 2006 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
0 (this device)K963189Erbe 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—
+1K024047Erbe Vio Apc with AccessoriesErbe USA, Inc.2003—
+1K030819Plasmajet SystemPlasma Surgical, Ltd.2004—
+2K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable…Bovie Medical2009—
+2K060183Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterErbe USA, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200310
200410
200530
200640
200730
200840
200930
201120
201230
201310
201420
201530
201730
201810
201970
202030
202140
202250
202350
202420
202550
FIG. 1 — Lineage of K963189, 1989–2025Source: 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), 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
*K903724Beamer 1,2,4,6, and 8
Summary page 1
…1996 2. Name of the Device: ERBE APC 300 Argon Plasma Coagulator and Accessories (APC probe for flexible endoscopes) 3. Predi Device Information: Beamer 1/2/4/6/8, K#903724 manufactured by Beacon Laboratories, Inc.; and Beacon B-101 Laparoscopic Switching Disposable Hand Piece, K#894762, manufactured…
Beacon Laboratories, Inc.1990—
*K894762B100 Disposable Handpiece
Summary page 1
…pes) 3. Predi Device Information: Beamer 1/2/4/6/8, K#903724 manufactured by Beacon Laboratories, Inc.; and Beacon B-101 Laparoscopic Switching Disposable Hand Piece, K#894762, manufactured by Beacon Laboratories, Inc. 4, Device Description: The APC 300 is a table-top device which allows for placement…
Beacon Laboratories, Inc.1989—

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…Erbe USA, Inc.200130
K024047Erbe Vio Apc with AccessoriesErbe USA, Inc.200325
K030819Plasmajet SystemPlasma Surgical, Ltd.200417
K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc.200514
K052035Canady Plasma ProbesCanady Technology, LLC20056
K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc.20062
K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc.20121
K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG20081
K042274PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd.20050
K992769Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109, 20132-110, 20132-11…Erbe USA, Inc.19990

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K013348 (Erbe USA, Inc., 2001) has gone furthest, with 30 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—

What is it indicated for?

The ERBE APC 300 Argon Plasma Coagulator is an argon gas delivery system that is designed for coagulation when used in combination with ERBE ICC Electrosurgery Generators and ERBE APC Probes.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Erbe USA, Inc.

39 FDA decisions under this applicant name. See the company

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  • K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
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  • K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
  • K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 20161 recall

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https://510kreport.com/device/K963189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963189

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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