510(k) · Cleared
ClearedSpetzler Malis Dual Illuminating Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergetics · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 12, 2016 as substantially equivalent to K121426 (Synergetics, Inc., 2012) after a 267-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Oct 12, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K884656 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
- 3 generations backK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
- 2 generations backK110924 Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · Recalled
- 1 generation backK121426 Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · Recalled
- This deviceK160103 Spetzler Malis Dual Illuminating Bipolar ForcepsSynergetics · 2016
- Descendant · cites it directly · 0 of its ownK213610 Kogent Disposable Copper Forceps, Kogent Disposable Irrigating…Katalyst Surgical, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent…Katalyst Surgical, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884656 | Disposable Bipolar Cord and Bipolar Forcep | Dermacare | 1988 | 1 |
| −3 | K080187 | Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps | Olsen Medical | 2008 | 1 |
| −2 | K110924 | Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps | Synergetics, Inc. | 2011 | 3 |
| −1 | K121426 | Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps | Synergetics, Inc. | 2012 | 19 |
| 0 (this device) | K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps | Synergetics | 2016 | — |
| +1 | K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps… | Katalyst Surgical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121426 | Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSummary page 4…Accessories Product Code: GEI FDA Panel: General and Plastic Surgery III. PREDICATE DEVICE Predicate Devices: Spetzler™ Malis® Standard Bipolar Forceps, K121426 (primary predicate) Karl Storz Xenon Light Source and Telescope, K962595… | 2012 |
| † | K962595 | Karl Storz Xenon 300 Light Source for Non-Flash Applications | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent… | 2022 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K213610 (Katalyst Surgical, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K121426.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160103 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160103: Spetzler Malis Dual Illuminating Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160103
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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