510(k) Report

510(k) · Cleared

Cleared

Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-

K992769510(k) TraditionalCleared Oct 14, 199958-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 Oct 14, 1999 as substantially equivalent to K902996 (Beacon Laboratories, Inc., 1990) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1989.

Decided
Oct 14, 1999
Review
58 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K894762 (1989). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1990: 2 other ancestorsK894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 1989K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 19961985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 19890
  1. Root · 2 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 1 generation backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. This deviceK992769 Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109…Erbe USA, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−1K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
0 (this device)K992769Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109, 20132-110…Erbe USA, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199410
FIG. 1 — Lineage of K992769, 1989–1999Source: 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? (3)

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
*K902996Argon Beam Laparoscopic Electrode
Summary page 1
…antially Equivalent Devices: The ERBE APC Applicators are substantially equivalent to the following legally marketed devices: Beacon’s Argon Beam Laparoscopic Electrode (K902996), Everest Medical’s Bipolar Laparoscopic Cutting Electrosurgical Needle (K945975), and ERBE USA’s APC Probes (K963189). Device…
Beacon Laboratories, Inc.1990—
*K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps
Summary page 1
…to the following legally marketed devices: Beacon’s Argon Beam Laparoscopic Electrode (K902996), Everest Medical’s Bipolar Laparoscopic Cutting Electrosurgical Needle (K945975), and ERBE USA’s APC Probes (K963189). Device Description: The APC Applicators are provided in various shaft lengths, shaft di…
Everest Medical Corp.1994—
*K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…
Summary page 1
…ices: Beacon’s Argon Beam Laparoscopic Electrode (K902996), Everest Medical’s Bipolar Laparoscopic Cutting Electrosurgical Needle (K945975), and ERBE USA’s APC Probes (K963189). Device Description: The APC Applicators are provided in various shaft lengths, shaft diameters, and bend angles to accommodat…
Erbe USA, Inc.1996—

Also cleared against K902996: 1 other device →

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 10 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
  • None of the 5 ancestors has a recall.
  • 1 other device also cites its predicate K902996.

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 Applicators’ intended use is for the delivery of argon gas plasma energy for coagulation of tissue.

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

Also cleared against K902996

1 other device cites the same predicate.

  • K992764Erbe Apc Raspatory Handle and Tip, Model 20132-102, 20132-103Erbe USA, Inc. · 1999

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
  • K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 20191 recall
  • 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/K992769 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992769: Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992769

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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