510(k) Report

510(k) · Cleared

Cleared

Bipolar Scissors

K972558510(k) TraditionalCleared Oct 7, 199790-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

Enable Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 7, 1997 as substantially equivalent to K951387 (Symbiosis Corp., 1995) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1994. 13 later devices descend from it.

Decided
Oct 7, 1997
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K945975 (1994). 5 ancestors in all. 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1999: 1 descendant cleared1998: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2000: 1 descendant cleared2003: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant cleared2012: 2 descendants cleared2013: 1 descendant clearedK945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 19940+5
  1. Root · 1 generation backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
  2. This deviceK972558 Bipolar ScissorsEnable Medical Corp. · 1997
  3. Descendant · cites it directly · 8 of its ownK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
  4. Descendant · cites it directly · 7 of its ownK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
  5. Descendant · 2 generations on · 6 of its ownK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
  6. Descendant · cites it directly · 4 of its ownK042077 Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004
  7. Descendant · 3 generations on · 3 of its ownK030890 SwitchbladeSnowden Pencer, Inc. · 2003

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12000: 12003: 12004: 12006: 12008: 12009: 12012: 22013: 12016: 12026: 1
1998high 2 (2012) · low 0 (2001)2026

Most influential descendants

Showing 5 of 13 · See all
  • K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998 · cites it directly8descendants
  • K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999 · cites it directly7descendants
  • K001330Sovereign Bipolar InstrumentsAesculap, Inc. · 2000 · 2 generations on6descendants
  • K042077Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004 · cites it directly4descendants
  • K030890SwitchbladeSnowden Pencer, Inc. · 2003 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp.1994—
0 (this device)K972558Bipolar ScissorsEnable Medical Corp.1997—
+1K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp.1998—
+1K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp.1999—
+2K001330Sovereign Bipolar InstrumentsAesculap, Inc.2000—
+1K042077Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH2004—
+3K030890SwitchbladeSnowden Pencer, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200010
200310
200410
200610
200810
200910
201220
201310
201610
202610
FIG. 1 — Lineage of K972558, 1994–2026Source: 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? (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
*K951387Symbiosis Bipolar Scissors
Summary page 1
…posable Cartridges Generic/Common Name: Electrosurgical cutting and coagulation device and accessories 21CFR878.4400 PREDICATED DEVICES 1. Symbiosis Bipolar Scissors (K951387) 2. Everest Medical Bipolar Scissors (K945975 and K955001) 3. CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 4. E…
Symbiosis Corp.1995—
*K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps
Summary page 1
…osurgical cutting and coagulation device and accessories 21CFR878.4400 PREDICATED DEVICES 1. Symbiosis Bipolar Scissors (K951387) 2. Everest Medical Bipolar Scissors (K945975 and K955001) 3. CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 4. Ethicon PowerStar Bipolar Scissors (K960476) 32…
Everest Medical Corp.1994—
*K955001Evershears Scissors, Bilap Probes, Bicoag Forceps
Summary page 1
…tting and coagulation device and accessories 21CFR878.4400 PREDICATED DEVICES 1. Symbiosis Bipolar Scissors (K951387) 2. Everest Medical Bipolar Scissors (K945975 and K955001) 3. CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 4. Ethicon PowerStar Bipolar Scissors (K960476) 32 === Page 2…
Everest Medical Corp.1995—
*K963930CTS Midcab/SVH Bipolar Scissors
Summary page 1
…CATED DEVICES 1. Symbiosis Bipolar Scissors (K951387) 2. Everest Medical Bipolar Scissors (K945975 and K955001) 3. CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 4. Ethicon PowerStar Bipolar Scissors (K960476) 32 ENABLE Medical Corporation Bipolar Scissors 510(k) INTENDED…
Cardiothoracic Systems, Inc.1997—
*K960476Ethicon Bipolar Scissors and Accessory Cable
Summary page 1
…51387) 2. Everest Medical Bipolar Scissors (K945975 and K955001) 3. CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 4. Ethicon PowerStar Bipolar Scissors (K960476) 32 ENABLE Medical Corporation Bipolar Scissors 510(k) INTENDED USE The ENABLE Bipolar Scissors with ENABLE Bi…
ETHICON, Inc.1996—

Also cleared against K951387: 3 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp.19988
K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp.19997
K042077Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH20044

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K981219 (Enable Medical Corp., 1998) has gone furthest, with 8 descendants of its own.
  • 3 other devices also cite its predicate K951387.

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 ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during general surgery.

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 K951387

3 other devices cite the same predicate.

  • K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  • K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
  • K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998

More from Enable Medical Corp.

4 FDA decisions under this applicant name. See the company

  • K010112Bipolar Coagulation SystemEnable Medical Corp. · 2001
  • K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
  • K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998

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The GEI category page

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https://510kreport.com/device/K972558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972558: Bipolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972558

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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