# K083781: Eea Hemorrhoid Stapler & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Devices, A Global Business Unit Covidien
- Decided: Feb 4, 2009 after 47 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K024275 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 1.
- K051301: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.

## Recalls of this device
- Apr 9, 2018 · Class II · Z-1527-2018: There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leadi
- Apr 9, 2018 · Class II · Z-1528-2018: There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leadi

## Indications for use
The EEATM Hemorrhoid Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEATM Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.

Source page: https://510kreport.com/device/K083781
Methodology: https://510kreport.com/methodology