510(k) · Cleared
Recalled · Class II · 2023Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergetics, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 10, 2012 as substantially equivalent to K110924 (Synergetics, Inc., 2011) after a 57-day review. Its family tree reaches back 3 generations to 1988. 7 later devices descend from it. It has been recalled 19 times.
- Decided
- Jul 10, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 19
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884656 (1988). 4 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
- 2 generations backK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
- 1 generation backK110924 Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · Recalled
- This deviceK121426 Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK162469 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps…Medos International SARL · 2016
- Descendant · 2 generations on · 1 of its ownK193587 Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK160103 Spetzler Malis Dual Illuminating Bipolar ForcepsSynergetics · 2016
- Descendant · cites it directly · 1 of its ownK123172 Kogent Bipolar ForcepsKatalyst Surgical, LLC · 2012
- Descendant · cites it directly · 0 of its ownK232703 Disposable Bipolar ForcepsJiangsu Hope Biomedical Science & Technology Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
2012high 2 (2016) · low 0 (2013)2026
Most influential descendants
Showing 5 of 7 · See all- K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim…Medos International SARL · 2016 · cites it directly2descendants
- K193587Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH · 2020 · 2 generations on1descendant
- K160103Spetzler Malis Dual Illuminating Bipolar ForcepsSynergetics · 2016 · cites it directly1descendant
- K123172Kogent Bipolar ForcepsKatalyst Surgical, LLC · 2012 · cites it directly1descendant
- K232703Disposable Bipolar ForcepsJiangsu Hope Biomedical Science & Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884656 | Disposable Bipolar Cord and Bipolar Forcep | Dermacare | 1988 | 1 |
| −2 | K080187 | Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps | Olsen Medical | 2008 | 1 |
| −1 | K110924 | Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps | Synergetics, Inc. | 2011 | 3 |
| 0 (this device) | K121426 | Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps | Synergetics, Inc. | 2012 | — |
| +1 | K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru… | Medos International SARL | 2016 | — |
| +2 | K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Sutter Medizintechnik GmbH | 2020 | 1 |
| +1 | K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps | Synergetics | 2016 | — |
| +1 | K123172 | Kogent Bipolar Forceps | Katalyst Surgical, LLC | 2012 | — |
| +1 | K232703 | Disposable Bipolar Forceps | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K110924 | Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSummary page 1…tic Surgery v Predicate Device: Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps, K 110924 Device Description: The SynergeticsTm Disposable Spetzlefrm Malis® Standard Bipolar Forceps are sterile single use devices fo… | 2011 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2023 | Class II | Z-0243-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0247-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0248-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0249-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0250-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0257-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0253-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0256-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0241-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0244-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0251-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0255-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0239-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0240-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0242-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0245-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0246-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0252-2024 | Under Investigation by firm | An 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, 2023 | Class II | Z-0254-2024 | Under Investigation by firm | An 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. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K162469 (Medos International SARL, 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K110924.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2007high 65 (2023) · low 35 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
2007high 183 (2026) · low 51 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
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
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
| 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 Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121426: Aynergetics Disposable Spetzler-Malis Standard 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/K121426
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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