# K032973: Reprocessed Disposable Cutters, Staplers and Appliers

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Dec 18, 2003 after 85 days
- Product code: GDW (Staple, Implantable)
- 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: 1 generation back to K821994 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843034: Disposable Linear Cutter, ETHICON, Inc. (1984) Summary page 1.
- K821994: Disposable Linear Stapler-(LSR), ETHICON, Inc. (1982) Summary page 1.
- K892927: Proximate Linear Cutter Thick Tissue Inst., ETHICON, Inc. (1989) Summary page 1.
- K830503: Ligaclip Titanium Ligating Clip, ETHICON, Inc. (1983) Summary page 1.

## Indications for use
Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.

Source page: https://510kreport.com/device/K032973
Methodology: https://510kreport.com/methodology