510(k) Report

510(k) · Cleared

Cleared

Non-Stick Bipolar Forceps

K992931510(k) TraditionalCleared Nov 17, 199978-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

Silverglide Surgical Technologies · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 17, 1999 as substantially equivalent to K970987 (Fusion Medical Technologies, Inc., 1997) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1992. 117 later devices descend from it.

Decided
Nov 17, 1999
Review
78 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K923332 (1992). 4 ancestors in all. 117 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor2001: 1 descendant cleared2007: 5 descendants cleared2015: 3 descendants cleared2005: 4 descendants cleared2010: 4 descendants cleared2011: 6 descendants cleared2004: 3 descendants cleared2008: 11 descendants cleared2002: 1 descendant cleared2006: 11 descendants cleared2022: 5 descendants cleared2009: 5 descendants cleared2013: 5 descendants cleared2012: 8 descendants cleared2016: 4 descendants cleared2003: 1 descendant cleared2014: 6 descendants cleared2021: 2 descendants cleared2020: 3 descendants cleared2019: 8 descendants cleared2018: 5 descendants cleared2017: 2 descendants cleared2025: 2 descendants cleared2024: 6 descendants cleared2026: 4 descendants cleared2023: 2 descendants clearedK923332 · Electrosurgical Electrodes · Premier Dental Products Co. · 1992K970987 · Electrosurgical Electrode · Fusion Medical Technologies, Inc. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 15 descendants3 generations forward: 15 descendants4 generations forward: 20 descendants5 generations forward: 22 descendants6 generations forward: 18 descendants7 generations forward: 10 descendants8 generations forward: 4 descendants9 generations forward: 4 descendants10 generations forward: 3 descendants K970987 · Electrosurgical Electrode · Fusion Medical Technologies, Inc. · 1997K923332 · Electrosurgical Electrodes · Premier Dental Products Co. · 19920+5+10
  1. Root · 2 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
  2. 1 generation backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
  3. This deviceK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
  4. Descendant · cites it directly · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  5. Descendant · 2 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  6. Descendant · 3 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  7. Descendant · 3 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
  8. Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004

Showing 5 of 117 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 32005: 42006: 112007: 52008: 112009: 52010: 42011: 62012: 82013: 52014: 62015: 32016: 42017: 22018: 52019: 82020: 32021: 22022: 52023: 22024: 62025: 22026: 4
2001high 11 (2006) · low 1 (2001)2026

Most influential descendants

Showing 5 of 117 · See all
  • K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · cites it directly92descendants
  • K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 2 generations on90descendants
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 3 generations on42descendants
  • K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 3 generations on34descendants
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K923332Electrosurgical ElectrodesPremier Dental Products Co.1992—
−1K970987Electrosurgical ElectrodeFusion Medical Technologies, Inc.1997—
0 (this device)K992931Non-Stick Bipolar ForcepsSilverglide Surgical Technologies1999—
+1K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
+2K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
+3K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
+3K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular2003—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200430
200540
2006110
200750
2008110
200950
201040
201160
201280
201350
201460
201530
201640
201720
201850
201980
202030
202120
202250
202320
202460
202520
202640
FIG. 1 — Lineage of K992931, 1992–2026Source: 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), 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
*K970987Electrosurgical Electrode
Summary page 1
…trosurgical cutting and coagulation device and accessories Proprietary Name: non-stick bipolar forceps Predicate Devices Ball Tip Electrode, Fusion Technologies, Inc., K970987 Midas Touch Bipolar Electrodes, ITI Medical Technologies, Inc., K982705 Device Description The Link Technology Non-Stick Bipolar…
Fusion Medical Technologies, Inc.1997—
*K982705Midas Touch Bipolar Forceps
Summary page 1
…Name: non-stick bipolar forceps Predicate Devices Ball Tip Electrode, Fusion Technologies, Inc., K970987 Midas Touch Bipolar Electrodes, ITI Medical Technologies, Inc., K982705 Device Description The Link Technology Non-Stick Bipolar Forceps electrode is an electrosurgical tool in the typical tweezers c…
Iti Medical Technologies, Inc.19981

What descends from it? (117)

See all 117

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

NumberDeviceApplicantDecidedDescendants
K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192
K051429Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH200521
K070997Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables…Pro-Med Instruments GmbH200714
K093108Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG201010
K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC20113
K150993NICO TRIOwandNico Corporation20151

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 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K011722 (AtriCure, Inc., 2001) has gone furthest, with 92 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—

What is it indicated for?

The Link Technology Non-Stick Bipolar Forceps product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K992931: Non-Stick Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992931

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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