510(k) · Cleared
ClearedDigital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 24, 1997 after a 115-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Oct 24, 1997
- Review
- 115 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972471 Digital 3-Chip Color Video Camera, Illuminators, Video Components…Smith & Nephew, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK003710 Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics…Smith & Nephew, Inc. · 2001
Most influential descendants
Showing 1 of 1 · See all- K003710Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera…Smith & Nephew, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972471 | Digital 3-Chip Color Video Camera, Illuminators, Video Components and… | Smith & Nephew, Inc. | 1997 | — |
| +1 | K003710 | Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics… | Smith & Nephew, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (4)
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 |
|---|---|---|---|
| * | — | Current product offerings from Smith & Nephew Named without a submission number | |
| * | — | Video components, surgical cameras, illuminators and accessories manufactured by Snowden… Named without a submission number | |
| * | — | Video components, surgical cameras, illuminators and accessories manufactured by Stryker… Named without a submission number | |
| * | — | Video components, surgical cameras, illuminators and accessories manufactured by Olympus Named without a submission number |
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 |
|---|---|---|---|
| K003710 | Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera… | 2001 | 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, K003710 (Smith & Nephew, Inc., 2001) 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?
Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope. Additionally, the Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera…
Read the full statement (109 words)
Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
Additionally, the Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liquid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.
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/K972471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972471: Digital 3-Chip Color Video Camera, Illuminators, Video Components 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/K972471
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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