# K132472: Justright 5MM Stapler, Justright 5MM Reload

- Pathway: 510(k) (Traditional)
- Applicant: Justright Surgical, LLC
- Decided: Feb 11, 2014 after 188 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: 1 generation back to K892233 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892233: Auto Suture (R) Endoscopic Gia (TM) Surgical Stapler, United States Surgical, A Division of Tyco Healthc (1989) Summary page 1.
- K900129: Modified Auto Suture Endoscopic Gia Surg. Stapler*, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K061095: Auto Sutur Endo Gia Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 1.

## Recalls of this device
- Aug 27, 2014 · Class II · Z-2690-2014: JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.
- Aug 27, 2014 · Class II · Z-2691-2014: JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

## Indications for use
The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Source page: https://510kreport.com/device/K132472
Methodology: https://510kreport.com/methodology