# K021236: Surgery and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Camtronics, Ltd.
- Decided: Jul 17, 2002 after 90 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K000380 (2000). 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)
- K011944: Dyonics Vision 635 Digital Capture System, Model 7209088, Smith & Nephew, Inc. (2001)

## Indications for use
Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.

Source page: https://510kreport.com/device/K021236
Methodology: https://510kreport.com/methodology