510(k) Report

510(k) · Cleared

Cleared

Sutter Electrosurgical Cables

K073450510(k) TraditionalCleared Mar 17, 200898-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

Sutter Medizintechnik GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 17, 2008 after a 98-day review. The FDA summary names no predicate by number. 7 later devices descend from it.

Decided
Mar 17, 2008
Review
98 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2024: 1 descendant cleared2014: 1 descendant cleared20052010201520202025
  1. This deviceK073450 Sutter Electrosurgical CablesSutter Medizintechnik GmbH · 2008
  2. Descendant · cites it directly · 3 of its ownK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
  3. Descendant · cites it directly · 1 of its ownK081678 Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
  4. Descendant · 2 generations on · 0 of its ownK241621 Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024
  5. Descendant · cites it directly · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
  6. Descendant · cites it directly · 0 of its ownK150024 Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12012: 22014: 12015: 22024: 1
2008high 2 (2012) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all
  • K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical · 2012 · cites it directly3descendants
  • K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008 · cites it directly1descendant
  • K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024 · 2 generations on0descendants
  • K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · cites it directly0descendants
  • K150024Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073450Sutter Electrosurgical CablesSutter Medizintechnik GmbH2008—
+1K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/…Olsen Medical20122
+1K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG2008—
+2K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical2024—
+1K143662Bissinger Monopolar Forceps and CablesMedagent, Inc.2015—
+1K150024Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201220
201410
201520
202410
FIG. 1 — Lineage of K073450, 2008–2024Source: 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical20123
K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG20081
K143662Bissinger Monopolar Forceps and CablesMedagent, Inc.20150
K150024Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH20150

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, K111262 (Olsen Medical, 2012) has gone furthest, with 3 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. 2008, this device’s year, is highlighted.

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?

To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073450: Sutter Electrosurgical Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073450

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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