510(k) Report

510(k) · Cleared

Cleared

Reusable Laparoscopic Instruments W/ Electrocautery

K930666510(k) TraditionalCleared May 19, 1994464-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

Snowden-Pencer · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 19, 1994 after a 464-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 275 devices in its family, counting itself, has a Class I recall. 274 later devices descend from it.

Decided
May 19, 1994
Review
464 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

274 later devices descend from it, 1 citing it directly. 1 of the 275 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1996: 1 descendant cleared2002: 5 descendants cleared1998: 1 descendant cleared2000: 1 descendant cleared1997: 1 descendant cleared2006: 3 descendants cleared2004: 4 descendants cleared2009: 3 descendants cleared2001: 1 descendant cleared2008: 6 descendants cleared2011: 8 descendants cleared2005: 5 descendants cleared2014: 12 descendants cleared2010: 1 descendant cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 7 descendants cleared2012: 4 descendants cleared2019: 12 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 6 descendants cleared2026: 23 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall11990200020102020
  1. This deviceK930666 Reusable Laparoscopic Instruments W/ ElectrocauterySnowden-Pencer · 1994
  2. Descendant · cites it directly · 273 of its ownK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. Descendant · 2 generations on · 269 of its ownK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. Descendant · 3 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  5. Descendant · 3 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  6. Descendant · 3 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004

Showing 5 of 274 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 12000: 12001: 12002: 52004: 42005: 52006: 32008: 62009: 32010: 12011: 82012: 42013: 72014: 122015: 62016: 112017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 312026: 23
1996high 31 (2025) · low 0 (1999)2026

Class I recalls in this family

  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 274 · See all
  • K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port…Snowden-Pencer · 1996 · cites it directly273descendants
  • K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Intuitive Surgical, Inc. · 2000 · 2 generations on269descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 3 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 3 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 3 generations on258descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930666Reusable Laparoscopic Instruments W/ ElectrocauterySnowden-Pencer1994—
+1K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
+2K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
+3K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+3K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+3K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
200010
200110
200250
200440
200550
200630
200860
200930
201010
201180
201240
201370
2014120
201560
2016110
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K930666, 1994–2026Source: 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.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (274)

See all 274

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

NumberDeviceApplicantDecidedDescendants
K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port…Snowden-Pencer1996273

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K960400 (Snowden-Pencer, 1996) has gone furthest, with 273 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—

More from Snowden-Pencer

10 FDA decisions under this applicant name. See the company

  • K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts)Snowden-Pencer · 1996
  • K930667Reusable Laparoscopic InstrumentsSnowden-Pencer · 199415 recalls
  • K924148Diamond-Sharp (R) TrocarsSnowden-Pencer · 1994
  • K924149Endo I/a ProbeSnowden-Pencer · 1993
  • K920985Snowden-Pencer Irrigation PumpSnowden-Pencer · 1992

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The GEI category page

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https://510kreport.com/device/K930666 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930666: Reusable Laparoscopic Instruments W/ Electrocautery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930666

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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