# K182160: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 5, 2018 after 88 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: 17 generations back to K930667 (1994). 90 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173866: Stryker AIM Light Source and SafeLight cable, Stryker (2018) Summary page 5.
- K151243: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit], Stryker Endoscopy (2015) Summary page 5.
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System, Stryker Endoscopy (2014) Summary page 5.
- K132785: Stryker 1488 HD Video Camera with Infrared Compatibility, Stryker Endoscopy (2013) Summary page 5.
- K150956: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies, Inc. (2016) Summary page 5.
- K161792: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies, Inc. (2016) Summary page 5.

## Most influential descendants
- K202592: Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) (2020), 26 descendants of its own
- K210088: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes (2021), 25 descendants of its own
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own
- K214046: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (2022), 14 descendants of its own
- K221611: 780 nm L11 LED Light Source with AIM (2022), 10 descendants of its own

## Recalls of this device
- Jan 14, 2022 · Class II · Z-0728-2022: A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, addit

## Indications for use
1688 4K Camera System with Advance Imaging Modality: The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. L11 LED Light Source with Advanced Imaging Modality: The L11 AIM Light Source and SafeLightTM Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K182160
Methodology: https://510kreport.com/methodology