510(k) · Cleared
ClearedMonik™ - Disposable Endoscopic Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M/s. Meril Endo Surgery Private Limited. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 24, 2024 as substantially equivalent to K032676 (Ethicon Endo-Surgery, Inc., 2003) and 1 other predicate after a 235-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- May 24, 2024
- Review
- 235 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032676 (2003). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK032676 Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath…Ethicon Endo-Surgery, Inc. · 2003 · Recalled
- 2 generations backK122511 Endopath Xcel Bladeless Trocar with Optiview Technology Endopath…Ethicon Endo-Surgery, LLC · 2012
- 1 generation backK190029 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019
- This deviceK233386 Monik™ - Disposable Endoscopic TrocarM/s. Meril Endo Surgery Private Limited. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip… | Ethicon Endo-Surgery, Inc. | 2003 | 6 |
| −2 | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt… | Ethicon Endo-Surgery, LLC | 2012 | — |
| −1 | K190029 | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip… | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2019 | — |
| 0 (this device) | K233386 | Monik™ - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 6…Trade Name Manufacturer 510 (K) No. ENDOPATH® III Bladeless Ethicon Endo-Surgery, Inc. K032676 MonikTM - Disposable Trocars (Primary Predicate) Endoscopic Trocar Disposable Bladeless Trocar Changzhou Xin Neng Y… | 2003 |
| * | K190029 | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…Summary page 6…y, Inc. K032676 MonikTM - Disposable Trocars (Primary Predicate) Endoscopic Trocar Disposable Bladeless Trocar Changzhou Xin Neng Yuan K190029 Medical Stapler Co., Ltd IV. Device Description The Disposable Endosc… | 2019 |
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 21 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2024, 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 Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
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/K233386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233386: Monik™ - Disposable Endoscopic Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233386
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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