510(k) · Cleared
ClearedOes Laparo-Thoraco Videoscope Type V
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 Mar 11, 1996 as substantially equivalent to K942838 (Olympus America, Inc., 1995) and 3 other predicates after a 105-day review. Its family tree reaches back 1 generation to 1993. 10 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 105 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K923982 (1993). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- This deviceK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- Descendant · cites it directly · 8 of its ownK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- Descendant · 2 generations on · 4 of its ownK081173 Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008
- Descendant · 3 generations on · 3 of its ownK111648 Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK201096 CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053382Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006 · cites it directly8descendants
- K081173Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008 · 2 generations on4descendants
- K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · 3 generations on3descendants
- K100533Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models…Vibrynt, Inc. · 2011 · 2 generations on1descendant
- K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| 0 (this device) | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| +1 | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| +2 | K081173 | Endoscopic CO2 Regulation Unit Ucr | Olympus Medical Systems Corporation | 2008 | — |
| +3 | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | Bracco Diagnostic, Inc. | 2011 | 1 |
| +2 | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
| +4 | K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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? (7)
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 |
|---|---|---|---|
| * | K942838 | Olympus Superview Laparoscope for OB/Gyn Our OCR of the scanned summary read K942338, FDA’s number for Olympus PF-8P Oes Pancreato Fiberscope and Accessories (Olympus Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus Flexible TipThoracoscope/ Laparoscope”. | 1995 |
| * | K942839 | Olympus Superview Laparoscope for General Surgery Our OCR of the scanned summary read K942339, FDA’s number for Skin Neuveau Scar Treatment (Puritas Health Care, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus Flexible TipThoracoscope/ Laparoscope”. | 1994 |
| * | K915857 | Flexible Tip Thoracoscope/LaparoscopeSummary page 2…aparo-ThoracoVideoscope Type V is substantially equivalent in design to the predicate Olympus OES LTF Flexible Tip Thoracoscope/Laparoscope which was cleared in 510(k) # K915857. The predicate LTF Flexible Tip Thoracoscope/Laparoscope is a fiberscope. The only difference between these two endoscopes is tha… | 1994 |
| * | K923982 | Olympus Oes Laparoscopy SystemSummary page 2…e is substantially equivalent in intended use, functions, and method of use to the T1020 Multiple Function Tube (Irrigation/Suction Probe) which was approved in 510(k) # K923982. Both devices have separate “plunger-like” valves that permit the operator to control when to activate the suction or irrigation… | 1993 |
| * | — | Lens Cleaner (Cook) Named without a submission number | |
| * | — | Optic Shaft (Wiest) Named without a submission number | |
| * | — | Lap Wash System (DevMed Group Inc.) Named without a submission number |
What descends from it? (10)
2 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?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K053382 (Olympus Medical Systems Corporation, 2006) has gone furthest, with 8 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 | — |
What is it indicated for?
OES Laparo-Thoraco Videoscope Type V The OES Laparo- Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity. A4907 Lens Cleaning Sheath The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface. A4908 Valve The A4908 Valve has been specifically designed for use in conjunction…
Read the full statement (166 words)
OES Laparo-Thoraco Videoscope Type V
The OES Laparo- Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity.
A4907 Lens Cleaning Sheath
The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface.
A4908 Valve
The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope.
Trocar Tube and Trocars
The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of CO, during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V.
The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.
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/K955403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955403: Oes Laparo-Thoraco Videoscope Type V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955403
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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