510(k) · Cleared
ClearedLENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 2, 2016 as substantially equivalent to K101734 (Visionscope Technologies, LLC, 2010) and 1 other predicate after a 168-day review. Its family tree reaches back 6 generations to 1983. 6 later devices descend from it.
- Decided
- Jun 2, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K833587 (1983). 35 ancestors in all, the oldest K771218 (1978). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 5 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 4 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 3 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 2 generations backK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
- 1 generation backK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- This deviceK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- Descendant · cites it directly · 3 of its ownK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- Descendant · 2 generations on · 2 of its ownK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- Descendant · 3 generations on · 1 of its ownK203566 Tablet ApplicationSmith & Nephew · 2021
- Descendant · cites it directly · 1 of its ownK191177 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit -…Smith and Nephew, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK221740 Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled…Smith and Nephew, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190367Smith & Nephew Tablet ApplicationSmith & Nephew · 2019 · cites it directly3descendants
- K192876INTELLIO Tablet ApplicationSmith & Nephew · 2020 · 2 generations on2descendants
- K203566Tablet ApplicationSmith & Nephew · 2021 · 3 generations on1descendant
- K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc. · 2019 · cites it directly1descendant
- K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −5 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −4 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −3 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −2 | K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | 2007 | — |
| −1 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| 0 (this device) | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| +1 | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| +2 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
| +3 | K203566 | Tablet Application | Smith & Nephew | 2021 | — |
| +1 | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi… | Smith and Nephew, Inc. | 2019 | — |
| +2 | K221740 | Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447)… | Smith and Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Summary page 4…ntal scientific technology to the following legally marketed device in commercial distribution: Primary: VisionScope High Definition Endoscopy Camera System, K101734 Secondary: 560 High Definition Camera System, K070266. E. Description of Device The Smith & Nephew LENS Integrated… | 2010 |
| * | K070266 | 560 High Definition Camera SystemSummary page 4…rketed device in commercial distribution: Primary: VisionScope High Definition Endoscopy Camera System, K101734 Secondary: 560 High Definition Camera System, K070266. E. Description of Device The Smith & Nephew LENS Integrated System is an integrated camera/ LED light source/ imag… | 2007 |
What descends from it? (6)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 4 of the 35 ancestors have a recall of any class.
- Of its descendants, K190367 (Smith & Nephew, 2019) has gone furthest, with 3 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. 2016, 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 Lens Integrated system and LENS Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals. Additionally, the LENS Integrated System and Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an…
Read the full statement (118 words)
The Lens Integrated system and LENS Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals.
Additionally, the LENS Integrated System and Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
The LENS Application, when used in conjunction with the LENS Integrated System WiFi version, is indicated for capture of still and motion pictures, patient file management and limited redundant control of the LENS camera control unit within articular cavities, body cavities, hollow organs, canals and the thoracic cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153606: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153606
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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