510(k) · Cleared
ClearedAesculap Endoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 19, 1994 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Apr 19, 1994
- Review
- 50 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK940936 Aesculap Endoscopic InstrumentsAesculap, Inc. · 1994
- Descendant · cites it directly · 17 of its ownK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- Descendant · 2 generations on · 13 of its ownK123102 Sovereign MiniAesculap, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
- Descendant · 4 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K982623Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998 · cites it directly17descendants
- K123102Sovereign MiniAesculap, Inc. · 2013 · 2 generations on13descendants
- K173919HX DeviceHuman Extension, Ltd. · 2018 · 3 generations on8descendants
- K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 4 generations on3descendants
- K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940936 | Aesculap Endoscopic Instruments | Aesculap, Inc. | 1994 | — |
| +1 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| +2 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| +3 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| +4 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
| +3 | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982623 (Aesculap, Inc., 1998) has gone furthest, with 17 descendants of its own.
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 | — |
https://510kreport.com/device/K940936 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940936: Aesculap Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940936
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026