510(k) Report

510(k) · Cleared

Recalled · Class III · 2018

Dan Monopolar Lap Accessories

K052759510(k) TraditionalCleared Jun 14, 2006257-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dannoritzer Medizintechnik GmbH & Co. KG · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 14, 2006 as substantially equivalent to K043013 (Miltex, Inc., 2005) and 1 other predicate after a 257-day review. Its family tree reaches back 3 generations to 1994. 8 later devices descend from it. It has been recalled once.

Decided
Jun 14, 2006
Review
257 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
2

Its longest line of descent runs back 3 generations to K932832 (1994). 7 ancestors in all, the oldest K913281 (1991). 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1994: 2 other ancestors1991: 1 other ancestor2008: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2012: 1 descendant clearedK932832 · Primus Insulated Forceps · Marlo Surgical Technology · 1994K021237 · Coopersurgical Laparoscopic Instruments · CooperSurgical, Inc. · 2003K043013 · Miltex Laparoscopic Instruments · Miltex, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 5 descendants4 generations forward: 1 descendant K043013 · Miltex Laparoscopic Instruments · Miltex, Inc. · 2005K021237 · Coopersurgical Laparoscopic Instruments · CooperSurgical, Inc. · 2003K932832 · Primus Insulated Forceps · Marlo Surgical Technology · 19940
  1. Root · 3 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
  2. 2 generations backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
  3. 1 generation backK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
  4. This deviceK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006
  5. Descendant · cites it directly · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
  6. Descendant · 2 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
  7. Descendant · 3 generations on · 1 of its ownK142208 Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
  8. Descendant · 3 generations on · 0 of its ownK230621 LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023
  9. Descendant · 4 generations on · 0 of its ownK230650 Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd. · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12012: 12014: 12015: 12019: 12023: 2
2008high 2 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all
  • K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · cites it directly7descendants
  • K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 2 generations on6descendants
  • K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · 3 generations on1descendant
  • K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023 · 3 generations on0descendants
  • K230650Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932832Primus Insulated ForcepsMarlo Surgical Technology1994—
−2K021237Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc.2003—
−1K043013Miltex Laparoscopic InstrumentsMiltex, Inc.2005—
0 (this device)K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG2006—
+1K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc.2008—
+2K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc.2011—
+3K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd.2015—
+3K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc.2023—
+4K230650Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201210
201410
201510
201910
202320
FIG. 1 — Lineage of K052759, 1994–2023Source: 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? (2)

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
*K043013Miltex Laparoscopic Instruments
Summary page 1
…al Cutting & Coagulation & Accessories (GEl, 21 CFR 878.4400) Predicate * Miltex Laparoscopic Instruments, Miltex, Inc., K043013 Devices: * Laparoscopic Electrode, Megadyne Medical Products, K040699 Device DAN Monopolar Lap Accessories co…
Miltex, Inc.2005—
*K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)
Summary page 1
…l, 21 CFR 878.4400) Predicate * Miltex Laparoscopic Instruments, Miltex, Inc., K043013 Devices: * Laparoscopic Electrode, Megadyne Medical Products, K040699 Device DAN Monopolar Lap Accessories consist of Description: * Standard insulated monopolar handles…
Megadyne Medical Products, Inc.2004—

Also cleared against K043013: 1 other device →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc.20087

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 6, 2018Class IIIZ-0062-2019Labeling False and MisleadingThe Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K081503 (National Advanced Endoscopy Devices, Inc., 2008) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K043013.

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?

DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes)

intended to be used in general laparoscopic surgical procedures requiring the use of

electrosurgical cutting and/or coagulation.

Indications for use as stated in the FDA summary.

Also cleared against K043013

1 other device cites the same predicate.

  • K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation · 20121 recall

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The GEI category page

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https://510kreport.com/device/K052759 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052759: Dan Monopolar Lap Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052759

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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