# K991416: Endoscopic Camera

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Jul 20, 1999 after 88 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: 2 generations back to K883943 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914883: Circon Acmi Gen Surg Instru for Mini Invasive Surg, Circon Video (1993) Summary page 1.
- K974391: Karl Storz Endovision XL Endoscopic Camera System, Karl Storz Imaging, Inc. (1998) Summary page 1.
- K950974: Karl Storz Endovision Digivideo (Digital Image Processor) Accessory for Color Television Camera Used in Endoscopic Procs, Karl Storz Imaging, Inc. (1995) Summary page 1.

## Indications for use
The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.

Source page: https://510kreport.com/device/K991416
Methodology: https://510kreport.com/methodology