510(k) · Cleared
ClearedStorz E8010 Ergotec/Premiere Adaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Feb 3, 1997 as substantially equivalent to K961310 (Storz Instrument Co., 1996) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Feb 3, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961310 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961310 Storz Premiere II Microsurgical System (CX Series)Storz Instrument Co. · 1996 · Recalled
- This deviceK964743 Storz E8010 Ergotec/Premiere AdaptorStorz Instrument Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961310 | Storz Premiere II Microsurgical System (CX Series) | Storz Instrument Co. | 1996 | 1 |
| 0 (this device) | K964743 | Storz E8010 Ergotec/Premiere Adaptor | Storz Instrument Co. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 1…10 ErgoTec™/Premiere® Adaptor and Storz ErgoTec Instrument Tips, is similar in design, function, and composition to the Storz CX7100 and CX7150 Microscissors Handpleces (K961310) and the existing Storz Microscissors Handpiece (K960061). v Predicate Comparison: A chart comparing characteristics of the Stor… | 1996 |
| * | K960061 | Storz D7108 Microscissors Handpiece/Storz D7106 Microscissors Drive TubeSummary page 1…t Tips, is similar in design, function, and composition to the Storz CX7100 and CX7150 Microscissors Handpleces (K961310) and the existing Storz Microscissors Handpiece (K960061). v Predicate Comparison: A chart comparing characteristics of the Storz D7108 Microscissors Handpiece, as it utilizes the new S… | 1996 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 10 other devices also cite its predicate K961310.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | 0 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTec™ Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964743: Storz E8010 Ergotec/Premiere Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964743
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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