510(k) Report

510(k) · Cleared

Cleared

Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf System

K073498510(k) TraditionalCleared Sep 19, 2008281-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

Rudolf Medical GmbH + Co. KG · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 19, 2008 as substantially equivalent to K062047 (PAJUNK GmbH Medizintechnologie, 2006) and 4 other predicates after a 281-day review. Its family tree reaches back 5 generations to 1994.

Decided
Sep 19, 2008
Review
281 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K945975 (1994). 29 ancestors in all, the oldest K923332 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2004: 2 other ancestors2001: 2 other ancestors1999: 2 other ancestors1998: 2 other ancestors1996: 3 other ancestors1997: 5 other ancestors1995: 3 other ancestors1994: 1 other ancestor1992: 1 other ancestorK945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 1994K972558 · Bipolar Scissors · Enable Medical Corp. · 1997K981219 · Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges · Enable Medical Corp. · 1998K992996 · Enable Endoscopic Bipolar Scissors · Enable Medical Corp. · 1999K001330 · Sovereign Bipolar Instruments · Aesculap, Inc. · 200019901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 10 other ancestors4 generations back: 3 other ancestors K001330 · Sovereign Bipolar Instruments · Aesculap, Inc. · 2000K992996 · Enable Endoscopic Bipolar Scissors · Enable Medical Corp. · 1999K981219 · Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges · Enable Medical Corp. · 1998K972558 · Bipolar Scissors · Enable Medical Corp. · 1997K945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 1994−50
  1. Root · 5 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
  2. 4 generations backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
  3. 3 generations backK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
  4. 2 generations backK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
  5. 1 generation backK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
  6. This deviceK073498 Laparoscopic and Electrosurgical Instruments and Accessories…Rudolf Medical GmbH + Co. KG · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp.1994—
−4K972558Bipolar ScissorsEnable Medical Corp.1997—
−3K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp.1998—
−2K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp.1999—
−1K001330Sovereign Bipolar InstrumentsAesculap, Inc.2000—
0 (this device)K073498Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy…Rudolf Medical GmbH + Co. KG2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199530
199630
199750
199820
199920
200120
200420
200520
200610
FIG. 1 — Lineage of K073498, 1994–2008Source: 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
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What was it cleared against? (5)

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
*K062047Adaptable Monopolar Adaptable and/or Retractable Electrodes
Summary page 2
…osurgical Instruments 3. Substantial Equivalence Rudolf s Laparoscopic and Electrosurgical Instruments are substantial equivalent to · PAJUNK GMBH MEDIZINTECHNOLOGIE, K062047 · GUNTER BISSINGER MEDIZINTECHNIK GMBH, K051429 * GUNTER BISSINGER MEDIZINTECHNIK GMBH, K042077 * ENABLE MEDICAL CORP., K01011…
PAJUNK GmbH Medizintechnologie2006—
*K051429Claris Non-Stick Bipolar Forceps
Summary page 2
…e Rudolf s Laparoscopic and Electrosurgical Instruments are substantial equivalent to · PAJUNK GMBH MEDIZINTECHNOLOGIE, K062047 · GUNTER BISSINGER MEDIZINTECHNIK GMBH, K051429 * GUNTER BISSINGER MEDIZINTECHNIK GMBH, K042077 * ENABLE MEDICAL CORP., K010112 a AESCULAP, INC., K001330 4. Description of…
Guenter Bissinger Medizintechnik GmbH2005—
*K042077Bitech Bipolar Scissors
Summary page 2
…uments are substantial equivalent to · PAJUNK GMBH MEDIZINTECHNOLOGIE, K062047 · GUNTER BISSINGER MEDIZINTECHNIK GMBH, K051429 * GUNTER BISSINGER MEDIZINTECHNIK GMBH, K042077 * ENABLE MEDICAL CORP., K010112 a AESCULAP, INC., K001330 4. Description of the Device Laparoscopic and electrosurgical inst…
Guenter Bissinger Medizintechnik GmbH2004—
*K010112Bipolar Coagulation System
Summary page 2
…to · PAJUNK GMBH MEDIZINTECHNOLOGIE, K062047 · GUNTER BISSINGER MEDIZINTECHNIK GMBH, K051429 * GUNTER BISSINGER MEDIZINTECHNIK GMBH, K042077 * ENABLE MEDICAL CORP., K010112 a AESCULAP, INC., K001330 4. Description of the Device Laparoscopic and electrosurgical instruments are used in various surgi…
Enable Medical Corp.2001—
*K001330Sovereign Bipolar Instruments
Summary page 2
…ECHNOLOGIE, K062047 · GUNTER BISSINGER MEDIZINTECHNIK GMBH, K051429 * GUNTER BISSINGER MEDIZINTECHNIK GMBH, K042077 * ENABLE MEDICAL CORP., K010112 a AESCULAP, INC., K001330 4. Description of the Device Laparoscopic and electrosurgical instruments are used in various surgical applications. Therefore…
Aesculap, Inc.2000—

Also cleared against K062047: 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 14 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
  • 1 of the 29 ancestors has a recall of any class.
  • 1 other device also cites its predicate K062047.

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?

Rudolf's laparoscopic and electrosurgical instruments are designed for dissecting, cutting and optional monopolar or bipolar coagulation of tissue during general surgical procedures.

These devices have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Indications for use as stated in the FDA summary.

Also cleared against K062047

1 other device cites the same predicate.

  • K190168Aquas ProbesGenicon, Inc. · 2019

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K073498 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073498: Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073498

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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