510(k) · Cleared
ClearedTrocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jakoubek Medizintechnik GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 27, 1999 after a 171-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 27, 1999
- Review
- 171 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK990785 Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, &…Jakoubek Medizintechnik GmbH · 1999
- Descendant · cites it directly · 0 of its ownK181173 ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated · 2019
Most influential descendants
Showing 1 of 1 · See all- K181173ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990785 | Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic… | Jakoubek Medizintechnik GmbH | 1999 | — |
| +1 | K181173 | ELMED Laparoscopic Instruments and Accessories | Elmed Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K181173 | ELMED Laparoscopic Instruments and Accessories | 2019 | 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?
- Of its descendants, K181173 (Elmed Incorporated, 2019) 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.
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?
Providing thorough irrigation and aspiration of the peritoneal cavity. Bleeders can be identified, bile, stones, tissue, blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry. Sole purpose of these instruments are to move tissue around. They can not grasp or restrain by means of grasping any body organ or tissue. They are introduced into the body cavity through a trocar sleeve. Once introduced they can only…
Read the full statement (262 words)
Providing thorough irrigation and aspiration of the peritoneal cavity. Bleeders can be identified, bile, stones, tissue, blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry.
Sole purpose of these instruments are to move tissue around. They can not grasp or restrain by means of grasping any body organ or tissue. They are introduced into the body cavity through a trocar sleeve. Once introduced they can only move tissue from side to side or up and down.
Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct observation and/or dissecting, cutting, repairing, removal or manipulation of internal tissues and/or organs.
Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said device. Internal tissues or organs may be visualized for either diagnostic or operative procedures.
Verres needles puncture through the abdominal wall to enable the introduction of gases into the abdominal cavity creating space between the fascia and the internal body organs, allowing for the safe introduction of laparoscopic instrumentation into the peritoneal cavity.
Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired.
Instruments which permit the grasping and manipulation of needles inside the peritoneal cavity enableing a surgeon to suture internal tissues during laparoscopic procedures.
Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy, cut, coagulate, manipulate or retrieve internal tissues or organs while performing laparoscopic procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990785: Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990785
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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