510(k) Report

510(k) · Cleared

Cleared

Bipolar Grasping Forceps Biq+

K984417510(k) TraditionalCleared Feb 24, 199976-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

Olympus America, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 24, 1999 as substantially equivalent to K945975 (Everest Medical Corp., 1994) and 4 other predicates after a 76-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.

Decided
Feb 24, 1999
Review
76 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K945975 (1994). 5 ancestors in all, the oldest K944201 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2014: 1 descendant clearedK945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 1994K971565 · Bicoag Coagulating Forceps · Everest Medical Corp. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K971565 · Bicoag Coagulating Forceps · Everest Medical Corp. · 1998K945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 19940
  1. Root · 2 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
  2. 1 generation backK971565 Bicoag Coagulating ForcepsEverest Medical Corp. · 1998
  3. This deviceK984417 Bipolar Grasping Forceps Biq+Olympus America, Inc. · 1999
  4. Descendant · cites it directly · 0 of its ownK140624 Hicura Hand InstrumentsOlympus Winter & Ibe GmbH · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K140624Hicura Hand InstrumentsOlympus Winter & Ibe GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp.1994—
−1K971565Bicoag Coagulating ForcepsEverest Medical Corp.1998—
0 (this device)K984417Bipolar Grasping Forceps Biq+Olympus America, Inc.1999—
+1K140624Hicura Hand InstrumentsOlympus Winter & Ibe GmbH2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K984417, 1994–2014Source: 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? (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
*K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps
Summary page 1
…ULATION & ACCESSORIES. Classification: CFR 878.4400 Class I Predicate Devices: Manufacturer Description S10(k) Everest Medical Corp. | BiCOAG® Bipolar Dissecting Forceps K945975 K955001 . K971565 Olympus A5380, AS382 Bipolar forceps, @5 mm, micro tweezers K955623 Olympus A5384, A5386 Bipolar forceps, @5 mm…
Everest Medical Corp.1994—
*K955001Evershears Scissors, Bilap Probes, Bicoag Forceps
Summary page 1
…& ACCESSORIES. Classification: CFR 878.4400 Class I Predicate Devices: Manufacturer Description S10(k) Everest Medical Corp. | BiCOAG® Bipolar Dissecting Forceps K945975 K955001 . K971565 Olympus A5380, AS382 Bipolar forceps, @5 mm, micro tweezers K955623 Olympus A5384, A5386 Bipolar forceps, @5 mm, tweeze…
Everest Medical Corp.1995—
*K971565Bicoag Coagulating Forceps
Summary page 1
…IES. Classification: CFR 878.4400 Class I Predicate Devices: Manufacturer Description S10(k) Everest Medical Corp. | BiCOAG® Bipolar Dissecting Forceps K945975 K955001 . K971565 Olympus A5380, AS382 Bipolar forceps, @5 mm, micro tweezers K955623 Olympus A5384, A5386 Bipolar forceps, @5 mm, tweezers, thin K…
Everest Medical Corp.1998—
*K955623Olympus Bipolar Forceps
Summary page 1
…turer Description S10(k) Everest Medical Corp. | BiCOAG® Bipolar Dissecting Forceps K945975 K955001 . K971565 Olympus A5380, AS382 Bipolar forceps, @5 mm, micro tweezers K955623 Olympus A5384, A5386 Bipolar forceps, @5 mm, tweezers, thin K955623 Olympus A5388, A5390 Bipolar forceps, @5 mm, tweezers, thick…
Olympus America, Inc.1996—
*K944201HI-Q Hand Instruments- Urology
Summary page 1
…Olympus A5388, A5390 Bipolar forceps, @5 mm, tweezers, thick K955623 Olympus A5392, A5394 Bipolar forceps, @5 mm, Hirsch K955623 Olympus A6124, A6322 HiQ Handinstruments K944201 Prepared & Submitted By: (Contact Person) Summary Preparation Date: Statement of Intended Use: Mrs. Laura Storms-Tyler Olympu…
Olympus America, Inc.1994—

Also cleared against K945975: 12 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K140624Hicura Hand InstrumentsOlympus Winter & Ibe GmbH20140

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 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K140624 (Olympus Winter & Ibe GmbH, 2014) has gone furthest, with 0 descendants of its own.
  • 12 other devices also cite its predicate K945975.

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 Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

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

Also cleared against K945975

12 other devices cite the same predicate.

  • K030512Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 20031 recall
  • K020143Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 20021 recall
  • K012598Reprocessed Laparoscopic Electric InstumentsSterilmed, Inc. · 20011 recall
  • K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  • K003897Endius Bipolar SheathEndius, Inc. · 2001
  • K993412Bitx ProbesEverest Medical Corp. · 2000

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

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The GEI category page

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https://510kreport.com/device/K984417 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984417: Bipolar Grasping Forceps Biq+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984417

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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