# K031593: Sopro 61D

- Pathway: 510(k) (Traditional)
- Applicant: Sopro
- Decided: Sep 16, 2003 after 118 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: 1 generation back to K936071 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936071: Smith & Nephew Dyonics Inc. Electronic Endoscope, Smith & Nephew Dyonics, Inc. (1994) Summary page 1.
- K000424: S51D Digital Endoscopy Camera, Sopro (2000)

## Most influential descendants
- K070102: Sopro 162 Camera (2007), 1 descendant of its own
- K082796: Sopro 184 Camera (2009), 0 descendants of its own

## Indications for use
Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device

Source page: https://510kreport.com/device/K031593
Methodology: https://510kreport.com/methodology