510(k) · Cleared
ClearedKARL STORZ New Generation Trocars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 18, 2018 as substantially equivalent to K940347 (KARL STORZ Endoscopy-America, Inc., 1994) after a 96-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jul 18, 2018
- Review
- 96 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940347 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK940347 Trocars, Cannulae and Sheaths for Endoscopic and Laparoscopic…KARL STORZ Endoscopy-America, Inc. · 1994
- This deviceK180977 KARL STORZ New Generation TrocarsKARL STORZ Endoscopy-America, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK254228 KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG · 2026
Most influential descendants
Showing 1 of 1 · See all- K254228KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940347 | Trocars, Cannulae and Sheaths for Endoscopic and Laparoscopic Procedures | KARL STORZ Endoscopy-America, Inc. | 1994 | — |
| 0 (this device) | K180977 | KARL STORZ New Generation Trocars | KARL STORZ Endoscopy-America, Inc. | 2018 | — |
| +1 | K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K940347 | Trocars, Cannulae and Sheaths for Endoscopic and Laparoscopic ProceduresSummary page 4…ral & Plastic Surgery Regulatory II Class: Product Code: GCJ Regulation: 21 CFR 876.1500 Predicate Primary Predicate Device: KARL STORZ Trocars (K940347) Device: The predicate device has not been subject to a design-related recall. Device The KARL STORZ… | 1994 |
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 |
|---|---|---|---|
| K254228 | KARL STORZ Trocars with Valve Seals | 2026 | 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?
- Its one ancestor has no recall.
- Of its descendants, K254228 (Karl Storz SE & CO. KG, 2026) 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. 2018, 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?
KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
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/K180977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180977: KARL STORZ New Generation Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180977
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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