510(k) · Cleared
ClearedS*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Feb 14, 1997 after a 368-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 14, 1997
- Review
- 368 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK960640 S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · 1997
- Descendant · cites it directly · 1 of its ownK101458 Lina Xcise Model Mor-1515Lina Medical Aps · 2011
- Descendant · 2 generations on · 0 of its ownK243821 i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
- Descendant · cites it directly · 0 of its ownK091010 Trokamed MorcellatorTrokamed GmbH · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK080365 Morce Power Plus and Variocarve MorcellatorNouvag AG · 2009
Most influential descendants
Showing 4 of 4 · See all- K101458Lina Xcise Model Mor-1515Lina Medical Aps · 2011 · cites it directly1descendant
- K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025 · 2 generations on0descendants
- K091010Trokamed MorcellatorTrokamed GmbH · 2011 · cites it directly0descendants
- K080365Morce Power Plus and Variocarve MorcellatorNouvag AG · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960640 | S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification) | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1997 | — |
| +1 | K101458 | Lina Xcise Model Mor-1515 | Lina Medical Aps | 2011 | — |
| +2 | K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025 | — |
| +1 | K091010 | Trokamed Morcellator | Trokamed GmbH | 2011 | 1 |
| +1 | K080365 | Morce Power Plus and Variocarve Morcellator | Nouvag AG | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2025 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 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, K101458 (Lina Medical Aps, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K960640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960640: S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960640
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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