510(k) · Cleared
ClearedTrocar System According to Hasson
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 12, 1999 as substantially equivalent to K923982 (Olympus Corp., 1993) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Jul 12, 1999
- Review
- 169 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K790071 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK790071 Endoscope and AccessoriesOlympus Corp. · 1979 · Recalled
- This deviceK990237 Trocar System According to HassonOlympus America, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790071 | Endoscope and Accessories | Olympus Corp. | 1979 | 6 |
| 0 (this device) | K990237 | Trocar System According to Hasson | Olympus America, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (7)
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 |
|---|---|---|---|
| * | K923982 | Olympus Oes Laparoscopy SystemSummary page 1…CESSORIES) Classification: CFR 876.1500 Class 1I and CFR 884.1720 Class II Predicate Devices: Manufacturer Description 510(k) Olympus AS5676 11 mm Trocar Tube, 125 mm K923982 A5673 11 mm Trocar, 225 mm, Conical tip K923982 05203 Trocar 11 mm, with valve and conical K790071 tip Karl Storz 30103 GO Troca… | 1993 |
| * | K790071 | Endoscope and AccessoriesSummary page 1…nufacturer Description 510(k) Olympus AS5676 11 mm Trocar Tube, 125 mm K923982 A5673 11 mm Trocar, 225 mm, Conical tip K923982 05203 Trocar 11 mm, with valve and conical K790071 tip Karl Storz 30103 GO Trocar, size 11 mm, consisting of: Unknown 30103 O Trocar only, with blunt tip 30103 G Cannula, 2 flang… | 1979 |
| * | — | Karl Storz 30103 GO Trocar, size 11 mm, consisting of 30103 O Trocar only, with blunt… Named without a submission number | |
| * | — | Karl Storz 30160 C1 Cone for trocars size 6 mm, black Named without a submission number | |
| * | — | Karl Storz 30101 Ct1 Cone for trocars size 7 mm, black Named without a submission number | |
| * | — | Karl Storz 30103 Ci Cone for trocars size 11 mm, black Named without a submission number | |
| * | — | Karl Storz 30101 C1 Cone for trocars size 13 mm, black Named without a submission number |
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?
- 2 of the 2 ancestors have a recall of any class.
- 4 other devices also cite its predicate K923982.
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?
The Olympus Trocar System according to Hasson has been designed for first puncture technique according to Hasson in laparoscopic applications.
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/K990237 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990237: Trocar System According to Hasson.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990237
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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