510(k) Report

510(k) · Cleared

Cleared

Bergen 710 Esu

K945861510(k) TraditionalCleared Mar 1, 199590-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

Bergen Mfg. · HAM Apparatus, Electrosurgical

Cleared on Mar 1, 1995 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 979 later devices descend from it.

Decided
Mar 1, 1995
Review
90 days
Class
Class II
Product code
HAM
Recalls
None
Predicates
0

979 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared2007: 12 descendants cleared2003: 9 descendants cleared2002: 4 descendants cleared1999: 1 descendant cleared2006: 8 descendants cleared2004: 6 descendants cleared2005: 12 descendants cleared2008: 26 descendants cleared2016: 50 descendants cleared2014: 37 descendants cleared2024: 92 descendants cleared2023: 66 descendants cleared2018: 48 descendants cleared2010: 27 descendants cleared2025: 131 descendants cleared2009: 20 descendants cleared2021: 47 descendants cleared2012: 19 descendants cleared2020: 47 descendants cleared2015: 36 descendants cleared2011: 20 descendants cleared2013: 26 descendants cleared2017: 52 descendants cleared2019: 35 descendants cleared2026: 76 descendants cleared2022: 70 descendants cleared1995200020052010201520202025
  1. This deviceK945861 Bergen 710 EsuBergen Mfg. · 1995
  2. Descendant · cites it directly · 978 of its ownK972299 Bergen Model 500 Electrosurgery GeneratorBergen Mfg. · 1997
  3. Descendant · 2 generations on · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  4. Descendant · 3 generations on · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  5. Descendant · 3 generations on · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
  6. Descendant · 4 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002

Showing 5 of 979 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12002: 42003: 92004: 62005: 122006: 82007: 122008: 262009: 202010: 272011: 202012: 192013: 262014: 372015: 362016: 502017: 522018: 482019: 352020: 472021: 472022: 702023: 662024: 922025: 1312026: 76
1997high 131 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 979 · See all
  • K972299Bergen Model 500 Electrosurgery GeneratorBergen Mfg. · 1997 · cites it directly978descendants
  • K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · 2 generations on977descendants
  • K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · 3 generations on973descendants
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · 3 generations on714descendants
  • K022266Aurora SRSyneron Medical, Ltd. · 2002 · 4 generations on705descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945861Bergen 710 EsuBergen Mfg.1995—
+1K972299Bergen Model 500 Electrosurgery GeneratorBergen Mfg.1997—
+2K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
+3K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
+3K012398Diomed 15 Diode LaserDiomed, Ltd.2002—
+4K022266Aurora SRSyneron Medical, Ltd.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200240
200390
200460
2005120
200680
2007120
2008260
2009200
2010270
2011200
2012190
2013260
2014370
2015360
2016500
2017520
2018480
2019350
2020470
2021470
2022700
2023660
2024920
20251310
2026760
FIG. 1 — Lineage of K945861, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (979)

See all 979

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972299Bergen Model 500 Electrosurgery GeneratorBergen Mfg.1997978

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, K972299 (Bergen Mfg., 1997) has gone furthest, with 978 descendants of its own.

How does its category compare?

All HAM devices

HAM Apparatus, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAM

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAM

Too few HAM 510(k)s in any year since 2007 to give a median.

Recalls per year · HAM

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HAM

2in 2025

2009: 12010: 12012: 12013: 12015: 12016: 32017: 32018: 62019: 112020: 32021: 12023: 32024: 12025: 2
2007high 11 (2019) · low 0 (2007)2025

MAUDE reports naming product code HAM, 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
20070—00
20080—00
20090—01
20100—01
20110—00
20120—11
20130—01
20140—00
20150—01
20161—03
20170—03
20180—06
20190—011
20200—03
20210—01
20220—00
20230—03
20240—01
20250—02
20260—0—

More from Bergen Mfg.

4 FDA decisions under this applicant name. See the company

  • K972299Bergen Model 500 Electrosurgery GeneratorBergen Mfg. · 1997
  • K964736Bergen 610 Bipolar CoagulatorBergen Mfg. · 1997
  • K863701Model 709 Bipolar Micro CoagulatorBergen Mfg. · 1986

Recent decisions in HAM

The HAM category page

  • K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd. · 2016
  • K000079Nikopad Electrosurgical Grounding Pad, Model 4777MNikomed U.S.A., Inc. · 20002 recalls
  • K993306Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model 4760 (Typically)Paladin Medical, Inc. · 1999
  • K913300Laparostat (TM)Cook Ob/Gyn · 1992
  • K920100Gsu Handpiece AdapterBeacon Laboratories, Inc. · 1992

https://510kreport.com/device/K945861 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945861: Bergen 710 Esu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945861

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