510(k) · Cleared
ClearedLina Xcise Model Mor-1515
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lina Medical Aps · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Mar 11, 2011 as substantially equivalent to K993801 (ETHICON, Inc., 2000) and 1 other predicate after a 289-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Mar 11, 2011
- Review
- 289 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960640 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK960640 S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · 1997
- This deviceK101458 Lina Xcise Model Mor-1515Lina Medical Aps · 2011
- Descendant · cites it directly · 0 of its ownK243821 i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960640 | S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification) | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1997 | — |
| 0 (this device) | K101458 | Lina Xcise Model Mor-1515 | Lina Medical Aps | 2011 | — |
| +1 | K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025 | — |
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 |
|---|---|---|
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K993801 | Gynecare Laparoscopic MorcellatorSummary page 1…are laparoscopic Morcellator [GYNECARE X-TR-ACT Tissue Morcellator] K993 80 1, cleared on 02/07/2000 (2)… | 2000 |
| * | K960640 | S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)Summary page 1…(2) S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) K960640, cleared on 02/14/1 997 Intended Use The LiNA Xcise Laparoscopic Morcellator is intended for gynaecologic endloscopic use by tr… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243821 | i-Cut | 2025 | 0 |
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?
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101458: Lina Xcise Model Mor-1515.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101458
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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