510(k) · Cleared
ClearedOes Laparo-Thoraco Videoscope (Rigid)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Feb 22, 1996 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 22, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK955456 Oes Laparo-Thoraco Videoscope (Rigid)Olympus America, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK111788 Endoeye HD IIOlympus America, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK190744 Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH · 2019 · Recalled
- Descendant · 2 generations on · 5 of its ownK193026 Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 4 of its ownK201200 Visera Elite II Video System CenterOlympus Medical Systems Corp. · 2020
- Descendant · 4 generations on · 2 of its ownK242067 Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite…Olympus Corporations of the Americas · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K111788Endoeye HD IIOlympus America, Inc. · 2012 · cites it directly10descendants
- K190744Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH · 2019 · 2 generations on6descendants
- K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020 · 2 generations on5descendants
- K201200Visera Elite II Video System CenterOlympus Medical Systems Corp. · 2020 · 3 generations on4descendants
- K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas · 2025 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955456 | Oes Laparo-Thoraco Videoscope (Rigid) | Olympus America, Inc. | 1996 | — |
| +1 | K111788 | Endoeye HD II | Olympus America, Inc. | 2012 | 2 |
| +2 | K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019 | 1 |
| +2 | K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020 | — |
| +4 | K242067 | Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led… | Olympus Corporations of the Americas | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 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, K111788 (Olympus America, Inc., 2012) has gone furthest, with 10 descendants 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/K955456 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955456: Oes Laparo-Thoraco Videoscope (Rigid).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955456
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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