510(k) · Cleared
ClearedWV1 Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
270surgical, Ltd. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Nov 1, 2019 as substantially equivalent to K111788 (Olympus America, Inc., 2012) after a 273-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Nov 1, 2019
- Review
- 273 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955456 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955456 Oes Laparo-Thoraco Videoscope (Rigid)Olympus America, Inc. · 1996
- 1 generation backK111788 Endoeye HD IIOlympus America, Inc. · 2012 · Recalled
- This deviceK190190 WV1 Endoscope270surgical, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK210104 SurroundScope System270surgical, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210104SurroundScope System270surgical, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955456 | Oes Laparo-Thoraco Videoscope (Rigid) | Olympus America, Inc. | 1996 | — |
| −1 | K111788 | Endoeye HD II | Olympus America, Inc. | 2012 | 2 |
| 0 (this device) | K190190 | WV1 Endoscope | 270surgical, Ltd. | 2019 | — |
| +1 | K210104 | SurroundScope System | 270surgical, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K111788 | Endoeye HD IISummary page 4…umber: CFR §884.1720 Product Code: HET Additional Product Code: GCJ per 21 CFR §876.1500 [Endoscope and Accessories] 3. Predicate Device Identification Predicate: K111788, Olympus, EndoEye HD The predicate device has been subject to a design-related recall. 4. Device Description The WV1 Syste… | 2012 |
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 |
|---|---|---|---|
| K210104 | SurroundScope System | 2021 | 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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K210104 (270surgical, Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K111788.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The WV1 endoscope is a reusable, rigid, video endoscope, designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190190: WV1 Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190190
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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