510(k) · Cleared

Recalled · Class II · 2012

Auto Suture Titanium Surgical Staples

K855047510(k) TraditionalCleared Jan 14, 198628-day reviewClass II21 CFR 878.4750Recalls 5

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

United States Surgical, A Division of Tyco Healthc · GDW Staple, Implantable

Cleared on Jan 14, 1986 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 5 times.

Decided: Jan 14, 1986
Review: 28 days
Class: Class II
Product code: GDW
Recalls: 5
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK855047 Auto Suture Titanium Surgical StaplesUnited States Surgical, A Division of Tyco Healthc · 1986
Descendant · cites it directly · 1 of its ownK093253 Amid StaplerSafestitch, LLC · 2009
Descendant · 2 generations on · 0 of its ownK120268 Amid StaplerSafestich Medical, LLC · 2012
Descendant · cites it directly · 0 of its ownK013860 Auto Suture Surgical StaplesUnited States Surgical, A Division of Tyco Healthc · 2001 · Recalled

Most influential descendants

Showing 3 of 3 · See all

K093253Amid StaplerSafestitch, LLC · 2009 · cites it directly1descendant
K120268Amid StaplerSafestich Medical, LLC · 2012 · 2 generations on0descendants
K013860Auto Suture Surgical StaplesUnited States Surgical, A Division of Tyco Healthc · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K855047	Auto Suture Titanium Surgical Staples	United States Surgical, A Division of Tyco Healthc	1986	—
+1	K093253	Amid Stapler	Safestitch, LLC	2009	—
+2	K120268	Amid Stapler	Safestich Medical, LLC	2012	—
+1	K013860	Auto Suture Surgical Staples	United States Surgical, A Division of Tyco Healthc	2001	8

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2009	1	0
2012	1	0

FIG. 1 — Lineage of K855047, 1986–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 15.1 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093253	Amid Stapler	Safestitch, LLC	2009	1
K013860	Auto Suture Surgical Staples	United States Surgical, A Division of Tyco Healthc	2001	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2012	Class II	Z-1844-2012	Package design/selection	Potential for the sterility barrier to be compromised.
May 9, 2012	Class II	Z-1847-2012	Package design/selection	Potential for the sterility barrier to be compromised.
May 9, 2012	Class II	Z-1846-2012	Package design/selection	Potential for the sterility barrier to be compromised.
May 9, 2012	Class II	Z-1848-2012	Package design/selection	Potential for the sterility barrier to be compromised.
May 9, 2012	Class II	Z-1845-2012	Package design/selection	Potential for the sterility barrier to be compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K093253 (Safestitch, LLC, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K855047 · printed Nov 4, 2026

Cite this page

510(k) Report. “K855047: Auto Suture Titanium Surgical Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K855047

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026