510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps

K110924510(k) TraditionalCleared Dec 7, 2011247-day reviewClass II21 CFR 878.4400Recalls 3

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

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

Cleared on Dec 7, 2011 as substantially equivalent to K080187 (Olsen Medical, 2008) after a 247-day review. Its family tree reaches back 2 generations to 1988. 8 later devices descend from it. It has been recalled 3 times.

Decided
Dec 7, 2011
Review
247 days
Class
Class II
Product code
GEI
Recalls
3
Predicates
1

Its longest line of descent runs back 2 generations to K884656 (1988). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2022: 1 descendant cleared2012: 2 descendants cleared2023: 1 descendant cleared2024: 1 descendant cleared2016: 2 descendants cleared2020: 1 descendant clearedK884656 · Disposable Bipolar Cord and Bipolar Forcep · Dermacare · 1988 · recalledK080187 · Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps · Olsen Medical · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K080187 · Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps · Olsen Medical · 2008 · recalledK884656 · Disposable Bipolar Cord and Bipolar Forcep · Dermacare · 1988 · recalled0
  1. Root · 2 generations backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
  2. 1 generation backK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
  3. This deviceK110924 Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011
  4. Descendant · cites it directly · 7 of its ownK121426 Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK162469 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps…Medos International SARL · 2016
  6. Descendant · 3 generations on · 1 of its ownK193587 Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH · 2020 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK160103 Spetzler Malis Dual Illuminating Bipolar ForcepsSynergetics · 2016
  8. Descendant · cites it directly · 1 of its ownK123172 Kogent Bipolar ForcepsKatalyst Surgical, LLC · 2012

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 22016: 22020: 12022: 12023: 12024: 1
2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · cites it directly7descendants
  • K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim…Medos International SARL · 2016 · 2 generations on2descendants
  • K193587Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH · 2020 · 3 generations on1descendant
  • K160103Spetzler Malis Dual Illuminating Bipolar ForcepsSynergetics · 2016 · 2 generations on1descendant
  • K123172Kogent Bipolar ForcepsKatalyst Surgical, LLC · 2012 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K884656Disposable Bipolar Cord and Bipolar ForcepDermacare19881
−1K080187Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical20081
0 (this device)K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc.2011—
+1K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc.201219
+2K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru…Medos International SARL2016—
+3K193587Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH20201
+2K160103Spetzler Malis Dual Illuminating Bipolar ForcepsSynergetics2016—
+1K123172Kogent Bipolar ForcepsKatalyst Surgical, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201620
202010
202210
202310
202410
FIG. 1 — Lineage of K110924, 1988–2024Source: 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), 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? (1)

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
*K080187Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps
Summary page 1
…Plastic Surgery Predicate Device: Olsen Medical Single Use Bayonet Bipolar Irrigating Bipolar Forceps, K080187 Device Desription: The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consi…
Olsen Medical20081

Also cleared against K080187: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc.20127
K123172Kogent Bipolar ForcepsKatalyst Surgical, LLC20121
K233346Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable…Hg Innovations, Ltd.20230
K213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent…Katalyst Surgical, LLC20220

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 11, 2023Class IIZ-0247-2024Under Investigation by firmAn error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Sep 11, 2023Class IIZ-0257-2024Under Investigation by firmAn error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Sep 11, 2023Class IIZ-0239-2024Under Investigation by firmAn error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K121426 (Synergetics, Inc., 2012) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K080187.

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. 2011, this device’s year, is highlighted.

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 Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

Indications for use as stated in the FDA summary.

Also cleared against K080187

2 other devices cite the same predicate.

  • K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use…Faulhaber Pinzetten Ohg · 2019
  • K102752Stingray Ultralite Disposable Irrigating Bipolar ForcepsStingray Surgical Products, Inc. · 2011

More from Synergetics, Inc.

16 FDA decisions under this applicant name. See the company

  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 201219 recalls
  • K121675VersavitSynergetics, Inc. · 20124 recalls
  • K113857Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 2012
  • K091441Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetSynergetics, Inc. · 2009
  • K071482Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. · 20071 recall

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The GEI category page

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https://510kreport.com/device/K110924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110924: Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110924

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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