510(k) · Cleared
ClearedLL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Image Laboratories, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 5, 1996 after a 196-day review. The FDA summary names its predicate without a number. 118 later devices descend from it.
- Decided
- Jul 5, 1996
- Review
- 196 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 1 citing it directly.
- This deviceK955845 LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod LensSurgical Image Laboratories, Inc. · 1996
- Descendant · cites it directly · 117 of its ownK013165 Usa Series LaparoscopesCircon Acmi · 2002
- Descendant · 2 generations on · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
- Descendant · 4 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K013165Usa Series LaparoscopesCircon Acmi · 2002 · cites it directly117descendants
- K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · 2 generations on106descendants
- K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 3 generations on104descendants
- K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 4 generations on103descendants
- K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955845 | LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens | Surgical Image Laboratories, Inc. | 1996 | — |
| +1 | K013165 | Usa Series Laparoscopes | Circon Acmi | 2002 | — |
| +2 | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | 1 |
| +3 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| +4 | K124031 | DA Vinci Fluorescence Imaging Vision System | Intuitive Surgical, Inc. | 2013 | — |
| +4 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 18 | 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? (6)
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 |
|---|---|---|---|
| * | — | Dyonics 8000 Laparoscope Named without a submission number | |
| * | — | Laparoscopes manufactured by Olympus Corporation Named without a submission number | |
| * | — | Laparoscopes manufactured by Richard Wolf Medical Instruments Corporation Named without a submission number | |
| * | — | Laparoscopes manufactured by Karl Storz Endoscopy Named without a submission number | |
| * | — | Laparoscopes manufactured by Smith & Nephew Dyonics Named without a submission number | |
| * | — | Laparoscopes manufactured by Stryker Endoscopes Named without a submission number |
What descends from it? (118)
See all 1181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013165 | Usa Series Laparoscopes | 2002 | 117 |
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, K013165 (Circon Acmi, 2002) has gone furthest, with 117 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 | — |
https://510kreport.com/device/K955845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955845: LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955845
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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