510(k) · Cleared
ClearedVeress Cannula and Modular Veress Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Oct 13, 2006 as substantially equivalent to K800668 (KARL STORZ Endoscopy-America, Inc., 1980) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 13, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940232 (1994). 14 ancestors in all, the oldest K800668 (1980). No later device cites it as a predicate yet.
- Root · 4 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 3 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 2 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 1 generation backK041321 Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp. · 2004
- This deviceK062097 Veress Cannula and Modular Veress CannulaPAJUNK GmbH Medizintechnologie · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −3 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −2 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −1 | K041321 | Veroscope Optical Veress Cannula & Dilation Tube System | Richard Wolf Medical Instruments Corp. | 2004 | — |
| 0 (this device) | K062097 | Veress Cannula and Modular Veress Cannula | PAJUNK GmbH Medizintechnologie | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K800668 | Cannula, W/Sharp Obturator & Veress NeedSummary page 1…ion Endloscopes and accessories Predicate Devices: 1. Cannula with sharp obturator & Veress Needle by Karl Storz K800668 2. Veress Cannula et al. by Richard Wolf Medical… | 1980 |
| * | K041321 | Veroscope Optical Veress Cannula & Dilation Tube SystemSummary page 1…Storz K800668 2. Veress Cannula et al. by Richard Wolf Medical K041 321 PMN Veress ModVer PMN 510k Veress GQ~doc Ca 2006-07-20… | 2004 |
| † | K911221 | Atraumatic Special Sprotte Needle | 1992 |
| † | K911202 | Atraumatic Standard Sprotte Needle | 1992 |
| † | K911260 | Atraumatic Standard Sprotte Needle | 1991 |
| † | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | 2004 |
| † | K033018 | Stimulong Plus Catheter Set Model, Various | 2004 |
| † | K012771 | Trocar Sleeve and Accessories, Models 1287-XX-XX | 2001 |
| † | K011997 | Modular Valve Handles for Adaptable Tubes, Model 1298-XX-XX, 1295-XX-XX | 2001 |
| † | K033249 | Pajunk Modular Handle Instruments | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
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 Pajunk insufflation cannula acc. Veress and the modular insufflation cannula acc. Veress is employed in minimal invasive surgery. The cannula is designed for the initial puncture with subsequent gas insuffation for laparoscopic operations. It is used to establish a pneumoperitoneum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062097: Veress Cannula and Modular Veress Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062097
Report an extraction error
Are you the manufacturer?
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