# K222504: H1

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Nov 10, 2022 after 84 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 K950862 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143640: KSEA CMOS Camera System (C-cam), KARL STORZ Endoscopy-America, Inc. (2015) Summary page 4.

## Indications for use
The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, fiberscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K222504
Methodology: https://510kreport.com/methodology