510(k) · Cleared
ClearedEndopath Ultra Veress Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · HIF Insufflator, Laparoscopic
Cleared on Feb 3, 1999 after a 90-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Feb 3, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK983925 Endopath Ultra Veress NeedleEthicon Endo-Surgery, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK061387 Veresure BellVeresure, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK070651 Aragon Surgical LapcapAragon Surgical, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK233020 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024
- Descendant · 3 generations on · 1 of its ownK073452 Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK041321 Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp. · 2004
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K061387Veresure BellVeresure, Inc. · 2006 · cites it directly5descendants
- K070651Aragon Surgical LapcapAragon Surgical, Inc. · 2007 · 2 generations on4descendants
- K233020TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024 · 3 generations on1descendant
- K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008 · 3 generations on1descendant
- K041321Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp. · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983925 | Endopath Ultra Veress Needle | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +1 | K061387 | Veresure Bell | Veresure, Inc. | 2006 | — |
| +2 | K070651 | Aragon Surgical Lapcap | Aragon Surgical, Inc. | 2007 | — |
| +3 | K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024 | — |
| +3 | K073452 | Modification to: Aragon Surgical Lapcap | Aragon Surgical, Inc. | 2008 | — |
| +1 | K041321 | Veroscope Optical Veress Cannula & Dilation Tube System | Richard Wolf Medical Instruments Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 HIF? 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 HIF device
- #1 K250388 Endoflator +score 15.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (9)
3 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, K061387 (Veresure, Inc., 2006) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIF
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIF
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HIF
1,507in 2025
MAUDE reports naming product code HIF, 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 | 4 | 140 | 0 | 8 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 4 | 191 | 0 | 21 |
| 2010 | 2 | — | 0 | 41 |
| 2011 | 5 | 128 | 0 | 44 |
| 2012 | 5 | 138 | 0 | 38 |
| 2013 | 2 | — | 0 | 40 |
| 2014 | 2 | — | 0 | 43 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 3 | 88 | 1 | 72 |
| 2017 | 5 | 242 | 0 | 68 |
| 2018 | 3 | 207 | 1 | 97 |
| 2019 | 2 | — | 0 | 128 |
| 2020 | 4 | 64 | 0 | 360 |
| 2021 | 1 | — | 0 | 654 |
| 2022 | 1 | — | 0 | 667 |
| 2023 | 7 | 134 | 1 (1) | 890 |
| 2024 | 4 | 170 | 0 | 1,483 |
| 2025 | 3 | 210 | 0 | 1,507 |
| 2026 | 3 | 265 | 12 | — |
What is it indicated for?
The ENDOPATH® Ultra Veress Insufflation Needle has applications in gynecologic laparoscopy and other minimally invasive abdominal procedures for establishment of pneumoperitoneum.
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/K983925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983925: Endopath Ultra Veress Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983925
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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