# K033578: Reprocessed Reloadable Cutters, Staplers, and Appliers

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Jul 11, 2005 after 606 days
- Product code: NLL (Staple, Implantable, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K821994 (1982). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.

## Indications for use
The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery. The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.

Source page: https://510kreport.com/device/K033578
Methodology: https://510kreport.com/methodology