510(k) · Cleared
ClearedELMED Laparoscopic Instruments and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elmed Incorporated · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 22, 2019 as substantially equivalent to K990785 (Jakoubek Medizintechnik GmbH, 1999) and 1 other predicate after a 324-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Mar 22, 2019
- Review
- 324 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990785 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK990785 Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, &…Jakoubek Medizintechnik GmbH · 1999
- This deviceK181173 ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990785 | Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic… | Jakoubek Medizintechnik GmbH | 1999 | — |
| 0 (this device) | K181173 | ELMED Laparoscopic Instruments and Accessories | Elmed Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K990785 | Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic InstrumentsSummary page 4…Number JAKOUBEK TROCAR & TROCAR SLEEVES, LAPAROSCOPES, K990785 MEDIZINTECHNIK GMBH LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS HANS HERMANN GMBH… | 1999 |
| * | K051610 | Hans Hermann Laparoscopes and AccessoriesSummary page 4…GMBH LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS HANS HERMANN GMBH HANS HERMANN LAPAROSCOPES AND ACCESSORIES K051610 11… | 2005 |
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?
- None of the 2 ancestors has a recall.
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 ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, dissecting, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue. The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by…
Read the full statement (242 words)
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, dissecting, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue.
The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current.
Manually operated surgical instruments are available with or without monopolar high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s).
Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator.
Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments.
Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure.
Instruments should be used only by personnel completely familiar with their operation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181173: ELMED Laparoscopic Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181173
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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