510(k) · Cleared
ClearedStryker Precision HD Camera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 23, 2014 as substantially equivalent to K132785 (Stryker Endoscopy, 2013) after a 38-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 23, 2014
- Review
- 38 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950862 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 2 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 1 generation backK132785 Stryker 1488 HD Video Camera with Infrared CompatibilityStryker Endoscopy · 2013 · Recalled
- This deviceK142603 Stryker Precision HD Camera SystemStryker Endoscopy · 2014
- Descendant · cites it directly · 1 of its ownK213860 ArthroFree Wireless Surgical Camera SystemLazurite Holdings, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK242606 Nuvis® Wireless HD Camera System (Nuvis-2K)Integrated Endoscopy, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −2 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −1 | K132785 | Stryker 1488 HD Video Camera with Infrared Compatibility | Stryker Endoscopy | 2013 | 3 |
| 0 (this device) | K142603 | Stryker Precision HD Camera System | Stryker Endoscopy | 2014 | — |
| +1 | K213860 | ArthroFree Wireless Surgical Camera System | Lazurite Holdings, LLC | 2022 | — |
| +2 | K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K132785 | Stryker 1488 HD Video Camera with Infrared CompatibilitySummary page 4…Compatibility Common Name 3-Chip Video Camera Premarket Notification K132785 Classification Name Laparoscope, General and Plastic Surgery Regulation Number… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213860 | ArthroFree Wireless Surgical Camera System | 2022 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K213860 (Lazurite Holdings, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K132785.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Stryker Precision HD Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are listed below. • laparoscopic cholecystectomy • laparoscopic hernia repair • laparoscopic appendectomy • laparoscopic pelvic lymph node dissection • laparoscopically assisted…
Read the full statement (150 words)
The Stryker Precision HD Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
A few examples of the more common endoscopic surgeries are listed below.
• laparoscopic cholecystectomy
• laparoscopic hernia repair
• laparoscopic appendectomy
• laparoscopic pelvic lymph node dissection
• laparoscopically assisted hysterectomy
• laparoscopic and thorascopic anterior spinal fusion
• anterior cruciate ligament reconstruction
• knee arthroscopy
• shoulder arthroscopy
• small joint arthroscopy
• decompression fixation
• wedge resection
• lung biopsy
• pleural biopsy
• dorsal sympathectomy
• pleurodesis
• internal mammary artery dissection for coronary artery bypass
• coronary artery bypass grafting where endoscopic visualization is indicated
• examination of the evacuated cardiac chamber during performance of valve replacement
The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142603: Stryker Precision HD 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/K142603
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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