# K983566: 3-Chip Video Camera

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jan 11, 1999 after 90 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950862 (1995). 1 ancestor in all.
130 later devices descend from it; 3 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950862: Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures, Karl Storz Imaging, Inc. (1995) Summary page 1.

## Most influential descendants
- K031098: 3-CCD Digital Camera System (2003), 124 descendants of its own
- K063457: Truehd (1080P) Digital Camera System (2006), 116 descendants of its own
- K091515: Spy Scope Intra-Operative Operating System (2009), 106 descendants of its own
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), 103 descendants of its own

## Recalls of this device
- Mar 31, 2008 · Not classified · Z-1558-2008: The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to 

## Indications for use
The Stryker Endoscopy 3-Chip Medical Video Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery where-ever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & 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 arery dissection for coronary artery bypass. coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Stryker Medical Video Camera are general surgeons. gynecologists. cardiac surgeons. thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Source page: https://510kreport.com/device/K983566
Methodology: https://510kreport.com/methodology