510(k) · Cleared
ClearedDisposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 26, 2019 as substantially equivalent to K122511 (Ethicon Endo-Surgery, LLC, 2012) and 1 other predicate after a 262-day review. Its family tree reaches back 2 generations to 2003. 5 later devices descend from it.
- Decided
- Sep 26, 2019
- Review
- 262 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K032676 (2003). 3 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003 · Recalled
- 1 generation backK122511 Endopath Xcel Bladeless Trocar with Optiview Technology Endopath…Ethicon Endo-Surgery, LLC · 2012
- This deviceK190029 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019
- Descendant · cites it directly · 1 of its ownK222695 troCarWash™ SystemBiotex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250820 Disposable TrocarsSinolinks Medical Innovation, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233386 Monik™ - Disposable Endoscopic TrocarM/s. Meril Endo Surgery Private Limited. · 2024
- Descendant · 2 generations on · 0 of its ownK233442 troCarWash™ SystemBiotex, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231042 Disposable Laparoscopic TrocarChangzhou Ankang Medical Instruments Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K222695troCarWash™ SystemBiotex, Inc. · 2023 · cites it directly1descendant
- K250820Disposable TrocarsSinolinks Medical Innovation, Inc. · 2025 · cites it directly0descendants
- K233386Monik™ - Disposable Endoscopic TrocarM/s. Meril Endo Surgery Private Limited. · 2024 · cites it directly0descendants
- K233442troCarWash™ SystemBiotex, Inc. · 2024 · 2 generations on0descendants
- K231042Disposable Laparoscopic TrocarChangzhou Ankang Medical Instruments Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip… | Ethicon Endo-Surgery, Inc. | 2003 | 6 |
| −1 | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt… | Ethicon Endo-Surgery, LLC | 2012 | — |
| 0 (this device) | K190029 | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip… | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2019 | — |
| +1 | K222695 | troCarWash™ System | Biotex, Inc. | 2023 | — |
| +1 | K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. | 2025 | — |
| +1 | K233386 | Monik™ - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. | 2024 | — |
| +2 | K233442 | troCarWash™ System | Biotex, Inc. | 2024 | — |
| +1 | K231042 | Disposable Laparoscopic Trocar | Changzhou Ankang Medical Instruments Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar…Summary page 5…e of lengths and diameters to accommodate different sizes surgical instrument 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K122511 Product Name: ENDOPATH® XCEL® Bladeless Trocar with OPTIVIEWTM Technology Predicate Device 2 510(k) Number: K062… | 2012 |
| * | K062326 | Autosuture Modified Versaport Trocar with Fixation Sleeve Our reading of the summary gave K062362, FDA’s number for Single Use Esophageal Manometey Catheters and Single Use… (Sarmed Srl). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Autosuture Modified Versaport Trocar with Fixation Sleeve”. | 2006 |
What descends from it? (5)
4 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K222695 (Biotex, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K122511.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190029 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190029: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190029
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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