510(k) · Cleared
ClearedLap-Wave 3000 (P07)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jul 23, 1999 as substantially equivalent to K935763 (W.O.M. World of Medicine GmbH, 1994) after a 140-day review. Its family tree reaches back 1 generation to 1994. 17 later devices descend from it.
- Decided
- Jul 23, 1999
- Review
- 140 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935763 (1994). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935763 SurgipumpW.O.M. World of Medicine GmbH · 1994
- This deviceK990732 Lap-Wave 3000 (P07)W.O.M. World of Medicine GmbH · 1999
- Descendant · cites it directly · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- Descendant · 2 generations on · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · 3 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 4 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · cites it directly15descendants
- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 2 generations on14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 3 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 4 generations on4descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935763 | Surgipump | W.O.M. World of Medicine GmbH | 1994 | — |
| 0 (this device) | K990732 | Lap-Wave 3000 (P07) | W.O.M. World of Medicine GmbH | 1999 | — |
| +1 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| +2 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| +3 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| +4 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +3 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K935763 | SurgipumpSummary page 1…e device to allow for removal of the fluid from the patient. The LAP-WAVE 3000 (P07) described in this notification is substantially equivalent to the device Surgipump, K935763, also manufactured by W.O.M. GmbH. The LAP-WAVE 3000 (P07) incorporates the same design features as the Surgipump, K935763. The o… | 1994 |
What descends from it? (17)
See all 172 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?
- Its one ancestor has no recall.
- Of its descendants, K062380 (W.O.M. World of Medicine AG, 2006) has gone furthest, with 15 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?
The LAP-WAVE 3000 (P07) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation.
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/K990732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990732: Lap-Wave 3000 (P07).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990732
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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