510(k) · Cleared
ClearedStryker Silverglide Bipolar Forceps Reusable Cable; Disposable Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 8, 2006 as substantially equivalent to K042608 (Tecno Instruments (Pvt.), Ltd., 2004) after a 71-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 8, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K042608 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042608 Tecno Reusable Bipolar Cables, Model 190-100 and 190-110Tecno Instruments (Pvt.), Ltd. · 2004
- This deviceK061835 Stryker Silverglide Bipolar Forceps Reusable Cable; Disposable CableStryker Instruments · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042608 | Tecno Reusable Bipolar Cables, Model 190-100 and 190-110 | Tecno Instruments (Pvt.), Ltd. | 2004 | — |
| 0 (this device) | K061835 | Stryker Silverglide Bipolar Forceps Reusable Cable; Disposable Cable | Stryker Instruments | 2006 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042608 | Tecno Reusable Bipolar Cables, Model 190-100 and 190-110Summary page 1…Electrosurgical cutting and coagulation device and accessories Classification Name: Bipolar Forceps Cable Equivalent to: K042608 Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable K023996 Modern Medical Equipment M… | 2004 |
| Kept off the family tree | K023996 | FDA’s K023996 is Aloka SSD-3500 Ultrasound System Our reading of the summary gave K023996, FDA’s number for Aloka SSD-3500 Ultrasound System (Aloka Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable”. Kept off the family tree. Summary page 1…Bipolar Forceps Cable Equivalent to: K042608 Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable K023996 Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable Device Description:… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K042608.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061835: Stryker Silverglide Bipolar Forceps Reusable Cable; Disposable Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061835
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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