510(k) · Cleared
ClearedPasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patton Surgical Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 29, 2008 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) and 2 other predicates after a 127-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- May 29, 2008
- Review
- 127 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K901407 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK901407 Core Disposable TrocarsCore Dynamics, Inc. · 1990
- 1 generation backK992324 Funnel TrocarPatton Medical Corp. · 1999
- This deviceK080161 Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded…Patton Surgical Corp. · 2008
- Descendant · cites it directly · 0 of its ownK130826 Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male…Stryker Endoscopy · 2013
Most influential descendants
Showing 1 of 1 · See all- K130826Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male LuerStryker Endoscopy · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901407 | Core Disposable Trocars | Core Dynamics, Inc. | 1990 | — |
| −1 | K992324 | Funnel Trocar | Patton Medical Corp. | 1999 | — |
| 0 (this device) | K080161 | Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar… | Patton Surgical Corp. | 2008 | — |
| +1 | K130826 | Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male Luer | Stryker Endoscopy | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 2…path® Blunt Tip Trocar, Endopath® Dilating Tip Trocar Mamufacturer: Ethicon Endo-Surgery, hi. 510(K) Number: K032676 Substantial Equivalence Date: 10/30/03 Product: Funnel Trocar Manufacturer: Patton Su… | 2003 |
| * | K992324 | Funnel TrocarSummary page 2…antial Equivalence Date: 10/30/03 Product: Funnel Trocar Manufacturer: Patton Surgical Corp. 510(K) Number: K992324 Substantial Equivalence Date: 08/19/99 Product: Shielded Surgical Trocar Manufacturer:… | 1999 |
| * | K971475 | Shielded Surgical TrocarSummary page 2…Date: 08/19/99 Product: Shielded Surgical Trocar Manufacturer: Ethicon Endo-Surgery, Inc. 510(K) Number: K971475 Substantial Equivalence Date: 08/21/97 -End of summary- sVICEs'… | 1997 |
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 |
|---|---|---|---|
| K130826 | Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male Luer | 2013 | 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 18 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K130826 (Stryker Endoscopy, 2013) has gone furthest, with 0 descendants of its own.
- 25 other devices also cite its predicate K032676.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The PassPort. Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures. The PassPort®Vortex Seal functions in combination with Patton Surgical's PassPort® Shielded Trocar to create and maintain a passageway for laparoscopic instruments during a variety…
Read the full statement (170 words)
The PassPort. Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort®Vortex Seal functions in combination with Patton Surgical's PassPort® Shielded Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopi6 procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety-of laparoscopic procedures such as general, gynecologic, thoracic, and uf'ological procedures.
The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopio instruments during a variety of laparoscopic procedures-such as general, gynecologic, thoracic, and urological procedures.
The PassPort®Cannula Anchor functions in combination with Patton Surgical's PassPort® Shielded Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080161 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080161: Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080161
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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