510(k) · Cleared
Recalled · 2012560 High Definition Camera System
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 Feb 22, 2007 as substantially equivalent to K031379 (Smith & Nephew, Inc., 2003) after a 24-day review. Its family tree reaches back 1 generation to 2003. 9 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031379 (2003). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031379 Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531Smith & Nephew, Inc. · 2003
- This deviceK070266 560 High Definition Camera SystemSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- Descendant · cites it directly · 6 of its ownK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- Descendant · 2 generations on · 3 of its ownK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- Descendant · 3 generations on · 2 of its ownK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- Descendant · 4 generations on · 1 of its ownK203566 Tablet ApplicationSmith & Nephew · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC · 2010 · cites it directly7descendants
- K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew · 2016 · cites it directly6descendants
- K190367Smith & Nephew Tablet ApplicationSmith & Nephew · 2019 · 2 generations on3descendants
- K192876INTELLIO Tablet ApplicationSmith & Nephew · 2020 · 3 generations on2descendants
- K203566Tablet ApplicationSmith & Nephew · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031379 | Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531 | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K070266 | 560 High Definition Camera System | Smith & Nephew, Inc. | 2007 | — |
| +1 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| +1 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| +2 | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| +3 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
| +4 | K203566 | Tablet Application | Smith & Nephew | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K031379 | Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531Summary page 2…conducted on the Smith & Nephew HID Camera System demonstrates substantial equivalence to the DYONICS Vision 325Z DV 3-CCD Hermes-Ready Camera System cleared in K031379. The testing also demonstrates that any differences in the new device and the predicate device do not raise any new issue… | 2003 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2012 | Not classified | Z-1479-2012 | Nonconforming Material/Component | May experience intermittent loss of video due to a defective board component |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K101734 (Visionscope Technologies, LLC, 2010) has gone furthest, with 7 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. 2007, 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 Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals when used with an appropriately indicated endoscope,
Additionally, when used in conjunction with a Smith & Nephew light source and light cable the Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070266: 560 High Definition Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070266
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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