510(k) · Cleared
ClearedOneport Surgical Trocar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 7, 2007 as substantially equivalent to K924761 (Richard-Allan Medical Ind., Inc., 1993) and 3 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Dec 7, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K924761 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K142464EntriportConmed Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924761 | Sterile Endoscopic Dispos Trocars W/Safe Shield | Richard-Allan Medical Ind., Inc. | 1993 | — |
| 0 (this device) | K073009 | Oneport Surgical Trocar System | Conmed Corporation | 2007 | — |
| +1 | K142464 | Entriport | Conmed Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldSummary page 1…anel: General & Plastic Surgery Obstetrics/Gynecology Regulation Number: 21 CFR 876.1500 Predicate Devices K924761 Reflex STIR Trocar Richard-Allan Medical Industries System K933456… | 1993 |
| * | K933456 | Comed Trogard (TM) Blunt Tip Trocar/SleeveSummary page 1…21 CFR 876.1500 Predicate Devices K924761 Reflex STIR Trocar Richard-Allan Medical Industries System K933456 ConMed TroGard Tm Blunt ConMed Corporation Tip Trocar System K952977… | 1993 |
| * | K952977 | Sabre Multi-Use Trocar SystemSummary page 1…ustries System K933456 ConMed TroGard Tm Blunt ConMed Corporation Tip Trocar System K952977 SABRE TM Multi-Use Trocar Endloscopic Concepts, Inc. System K001697… | 1995 |
| * | K001597 | Conmed Trogard Finesse Trocar System, Model 60-6050-XXX Our reading of the summary gave K001697, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ConMed TroGARD Finesse Trocar System”. | 2000 |
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 |
|---|---|---|---|
| K142464 | Entriport | 2015 | 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K142464 (Conmed Corporation, 2015) has gone furthest, with 0 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. 2007, 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 CONMED OnePort® Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of abdominal entry and access for endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073009: Oneport Surgical Trocar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073009
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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