510(k) Report

510(k) · Cleared

Recalled · 2009

Clearglide Precision Bipolar Device

K003587510(k) TraditionalCleared Dec 4, 200013-day reviewClass II21 CFR 878.4400Recalls 10

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

ETHICON, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 4, 2000 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 10 times.

Decided
Dec 4, 2000
Review
13 days
Class
Class II
Product code
GEI
Recalls
10
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK003587 Clearglide Precision Bipolar DeviceETHICON, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
  3. Descendant · 2 generations on · 1 of its ownK040584 NMX-1000Neomedix Corp. · 2004
  4. Descendant · 3 generations on · 0 of its ownK220891 Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024
  5. Descendant · cites it directly · 0 of its ownK102983 Vascuclear Precision BipolarSorin Group USA, Inc. · 2010
  6. Descendant · cites it directly · 0 of its ownK012033 Multifunction Endoscopic InstrumentSeedling Enterprises., LLC · 2001

Most influential descendants

Showing 5 of 5 · See all
  • K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 2003 · cites it directly2descendants
  • K040584NMX-1000Neomedix Corp. · 2004 · 2 generations on1descendant
  • K220891Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024 · 3 generations on0descendants
  • K102983Vascuclear Precision BipolarSorin Group USA, Inc. · 2010 · cites it directly0descendants
  • K012033Multifunction Endoscopic InstrumentSeedling Enterprises., LLC · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003587Clearglide Precision Bipolar DeviceETHICON, Inc.2000—
+1K024304Microsurgical Bipolar HandpieceNeomedix Corp.2003—
+2K040584NMX-1000Neomedix Corp.2004—
+3K220891Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc.2024—
+1K102983Vascuclear Precision BipolarSorin Group USA, Inc.2010—
+1K012033Multifunction Endoscopic InstrumentSeedling Enterprises., LLC2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200410
201010
202410
FIG. 1 — Lineage of K003587, 2000–2024Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K024304Microsurgical Bipolar HandpieceNeomedix Corp.20032
K102983Vascuclear Precision BipolarSorin Group USA, Inc.20100
K012033Multifunction Endoscopic InstrumentSeedling Enterprises., LLC20010

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2009Not classifiedZ-0625-2010Component change controlVessel clamping device may break during use.
Nov 25, 2009Not classifiedZ-0624-2010Component change controlVessel clamping device may break during use.
Nov 25, 2009Not classifiedZ-0630-2010Component change controlVessel clamping device may break during use.
Nov 25, 2009Not classifiedZ-0628-2010Component change controlVessel clamping device may break during use.
Nov 25, 2009Not classifiedZ-0626-2010Component change controlVessel clamping device may break during use.
Nov 25, 2009Not classifiedZ-0627-2010Component change controlVessel clamping device may break during use.
Nov 25, 2009Not classifiedZ-0629-2010Component change controlVessel clamping device may break during use.
May 7, 2007Not classifiedZ-1156-2007OtherDatascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed…
May 7, 2007Not classifiedZ-1158-2007OtherDatascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed…
May 7, 2007Not classifiedZ-1157-2007OtherDatascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed…

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K024304 (Neomedix Corp., 2003) has gone furthest, with 2 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—

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https://510kreport.com/device/K003587 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003587: Clearglide Precision Bipolar Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003587

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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