510(k) Report

510(k) · Cleared

Cleared

Model 50 Bipolar Coagulator

K972350510(k) TraditionalCleared Aug 21, 199758-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

Boston Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 21, 1997 after a 58-day review. The FDA summary names no predicate by number. 978 later devices descend from it.

Decided
Aug 21, 1997
Review
58 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 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 deviceK972350 Model 50 Bipolar CoagulatorBoston Surgical Products, Inc. · 1997
  2. Descendant · cites it directly · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  3. Descendant · 2 generations on · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  4. Descendant · 2 generations on · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
  5. Descendant · 3 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002
  6. Descendant · 3 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002

Showing 5 of 978 descendants. See all descendants

Descendants cleared per year

1998: 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
1998high 131 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 978 · See all
  • K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · cites it directly977descendants
  • K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · 2 generations on973descendants
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · 2 generations on714descendants
  • K022266Aurora SRSyneron Medical, Ltd. · 2002 · 3 generations on705descendants
  • K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 3 generations on695descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972350Model 50 Bipolar CoagulatorBoston Surgical Products, Inc.1997—
+1K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
+2K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
+2K012398Diomed 15 Diode LaserDiomed, Ltd.2002—
+3K022266Aurora SRSyneron Medical, Ltd.2002—
+3K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D…Dornier Medtech America, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K972350, 1997–2026Source: 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), 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?

The FDA summary names no predicate by number.

What descends from it? (978)

See all 978

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

NumberDeviceApplicantDecidedDescendants
K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998977

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, K974521 (Vnus Medical Technologies, Inc., 1998) has gone furthest, with 977 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 Boston Surgacal Products, Inc. Model 50 Coagulator Generator is a general purposd solid state bipofar generator to supply the RF signal to clectrosurgical handpieces used to coagulate soft bgdy tissues where a wide range of tissue types, patent conditions, and load impedances are encountered.

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

More from Boston Surgical Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K972311Model 20 Bipolar CoagulatorBoston Surgical Products, Inc. · 1997
  • K944947Electrosurgical Cutting & Coagulation Device & AccessBoston Surgical Products, Inc. · 1995
  • K953012Disposable & Reusable Surgical Cutting ToolsBoston Surgical Products, Inc. · 1995
  • K950375Disposable & Reusable Bipolar Suction CoagulatorBoston Surgical Products, Inc. · 1995
  • K951912Disoposable & Resuable Monpolar CordBoston Surgical Products, Inc. · 1995

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https://510kreport.com/device/K972350 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972350: Model 50 Bipolar Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972350

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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