510(k) · Cleared
Recalled · Class II · 2018Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 30, 2003 after a 62-day review. The FDA summary names its predicate without a number. 172 later devices descend from it. It has been recalled 6 times.
- Decided
- Oct 30, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 6
- Predicates
- 0
172 later devices descend from it, 26 citing it directly.
- This deviceK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003
- Descendant · cites it directly · 69 of its ownK070158 R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- Descendant · cites it directly · 68 of its ownK073170 R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- Descendant · 2 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- Descendant · cites it directly · 54 of its ownK063859 Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007
- Descendant · cites it directly · 51 of its ownK083211 Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
Showing 5 of 172 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 172 · See all- K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007 · cites it directly69descendants
- K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007 · cites it directly68descendants
- K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · 2 generations on58descendants
- K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007 · cites it directly54descendants
- K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008 · cites it directly51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip… | Ethicon Endo-Surgery, Inc. | 2003 | — |
| +1 | K070158 | R-Port Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| +1 | K073170 | R-Port II Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| +2 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| +1 | K063859 | Surgiquest Elastomeric Optical Trocar & Cannula | Surgiquest, Inc. | 2007 | — |
| +1 | K083211 | Airseal Optical Trocar & Cannula System | Surgiquest, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 8 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 13 | 0 |
| 2024 | 19 | 0 |
| 2025 | 15 | 0 |
| 2026 | 14 | 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? (6)
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 |
|---|---|---|---|
| * | — | ENDOPATH' Dilating Tip Trocar Named without a submission number | |
| * | — | ENDOPATH@Non-Bladed Obturator and Sleeve Named without a submission number | |
| * | — | ENDOPATH@Bladeless Trocar Named without a submission number | |
| * | — | ENDOPATH@Blunt Tip Trocar Named without a submission number | |
| * | — | ENDOPATH@OneSeal Reducer Cap Named without a submission number | |
| * | — | ENDOPATH' TRISTARTMLow Profile Trocars with Threaded Sleeve Named without a submission number |
What descends from it? (172)
See all 17226 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070158 | R-Port Laparoscopic Access Device | 2007 | 69 |
| K073170 | R-Port II Laparoscopic Access Device | 2007 | 68 |
| K063859 | Surgiquest Elastomeric Optical Trocar & Cannula | 2007 | 54 |
| K083211 | Airseal Optical Trocar & Cannula System | 2008 | 51 |
| K090902 | Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003 | 2009 | 46 |
| K071571 | Surgiquest Airseal Optical Trocar & Cannula System | 2007 | 36 |
| K112358 | Unimax Trocar System | 2011 | 16 |
| K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar… | 2012 | 14 |
| K073719 | Asc Triport Laparoscopic Access Device | 2008 | 13 |
| K120640 | Insuflow Synergy Port | 2012 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2018 | Class II | Z-1889-2018 | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator… |
| Mar 26, 2018 | Class II | Z-1885-2018 | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator… |
| Mar 26, 2018 | Class II | Z-1888-2018 | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator… |
| Mar 26, 2018 | Class II | Z-1886-2018 | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator… |
| Mar 26, 2018 | Class II | Z-1887-2018 | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator… |
| Sep 27, 2010 | Not classified | Z-0336-2011 | Device Design | This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070158 (Advanced Surgical Concepts, 2007) has gone furthest, with 69 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ENDOPATH@I11 Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments, The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH@I11 Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH@I11 Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032676
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