510(k) · Cleared

Recalled · Class II · 2014

Justright 5MM Stapler, Justright 5MM Reload

K132472510(k) TraditionalCleared Feb 11, 2014188-day reviewClass II21 CFR 878.4750Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Justright Surgical, LLC · GDW Staple, Implantable

Cleared on Feb 11, 2014 as substantially equivalent to K892233 (United States Surgical, A Division of Tyco Healthc, 1989) and 2 other predicates after a 188-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 2 times.

Decided: Feb 11, 2014
Review: 188 days
Class: Class II
Product code: GDW
Recalls: 2
Predicates: 3

Its longest line of descent runs back 1 generation to K892233 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK892233 Auto Suture (R) Endoscopic Gia (TM) Surgical StaplerUnited States Surgical, A Division of Tyco Healthc · 1989
This deviceK132472 Justright 5MM Stapler, Justright 5MM ReloadJustright Surgical, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K892233	Auto Suture (R) Endoscopic Gia (TM) Surgical Stapler	United States Surgical, A Division of Tyco Healthc	1989	—
0 (this device)	K132472	Justright 5MM Stapler, Justright 5MM Reload	Justright Surgical, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
2006	1	0

FIG. 1 — Lineage of K132472, 1989–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GDW device

#1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K892233	Auto Suture (R) Endoscopic Gia (TM) Surgical Stapler Summary page 1 …ntable Staple Classification Name: Implantable Staple Regulation Number(s): 878.4750 Predicate Devices: Covidien Endo GIATM 30mm 2.0 Size Staple, K892233, K900129, K061095, Intended Use: The JustRight T m 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thor…	United States Surgical, A Division of Tyco Healthc	1989	—
*	K900129	Modified Auto Suture Endoscopic Gia Surg. Stapler* Summary page 1 …aple Classification Name: Implantable Staple Regulation Number(s): 878.4750 Predicate Devices: Covidien Endo GIATM 30mm 2.0 Size Staple, K892233, K900129, K061095, Intended Use: The JustRight T m 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surg…	United States Surgical, A Division of Tyco Healthc	1990	—
*	K061095	Auto Sutur Endo Gia Staplers Summary page 1 …ssification Name: Implantable Staple Regulation Number(s): 878.4750 Predicate Devices: Covidien Endo GIATM 30mm 2.0 Size Staple, K892233, K900129, K061095, Intended Use: The JustRight T m 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for r…	United States Surgical, A Division of Tyco Healthc	2006	—

Also cleared against K892233: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 27, 2014	Class II	Z-2690-2014	Process design	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	Process design	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
2 other devices also cite its predicate K892233.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	56	9	2,401
2008	7	57	0	2,380
2009	13	27	22	4,014
2010	10	39	2	3,768
2011	11	49	9	3,826
2012	9	45	11 (1)	3,717
2013	13	49	1	3,777
2014	15	63	0	4,784
2015	8	111	6	4,899
2016	11	96	2	5,106
2017	13	103	3	11,643
2018	7	90	3	14,914
2019	12	205	4 (4)	16,600
2020	10	88	11	12,332
2021	9	233	0	13,015
2022	7	89	0	13,605
2023	4	267	1	14,623
2024	2	—	0	13,280
2025	3	111	3	11,905
2026	3	141	0	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132472: Justright 5MM Stapler, Justright 5MM Reload.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132472

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026