# K230605: 1788 4K Camera System with Advanced Imaging Modality

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Mar 31, 2023 after 28 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K930667 (1994). 120 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230216: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), Stryker (2023) Summary page 4.
- K214046: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable, Stryker (2022) Summary page 4.

## Most influential descendants
- K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (2023), 5 descendants of its own
- K233327: 1788 4K Camera System with Advanced Imaging Modality (2024), 1 descendant of its own
- K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (2026), 0 descendants of its own
- K260695: da Vinci Firefly Imaging System (2026), 0 descendants of its own
- K260185: 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (2026), 0 descendants of its own

## Indications for use
The 1788 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 Video Camera is indicated for use in adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee 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 and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1788 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.

Source page: https://510kreport.com/device/K230605
Methodology: https://510kreport.com/methodology