510(k) · Cleared

Cleared

Reprocessed Disposable Cutters, Staplers and Appliers

K032973510(k) TraditionalCleared Dec 18, 200385-day reviewClass II21 CFR 878.4750

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

Vanguard Medical Concepts, Inc. · GDW Staple, Implantable

Cleared on Dec 18, 2003 as substantially equivalent to K843034 (ETHICON, Inc., 1984) and 3 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1982.

Decided: Dec 18, 2003
Review: 85 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K821994 (1982). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
This deviceK032973 Reprocessed Disposable Cutters, Staplers and AppliersVanguard Medical Concepts, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K821994	Disposable Linear Stapler-(LSR)	ETHICON, Inc.	1982	—
0 (this device)	K032973	Reprocessed Disposable Cutters, Staplers and Appliers	Vanguard Medical Concepts, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1984	1	0
1989	1	0

FIG. 1 — Lineage of K032973, 1982–2003Source: 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 15.1 · 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? (4)

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
*	K843034	Disposable Linear Cutter Summary page 1 …uard reprocessed devices are substantially equivalent to Ethicon Linear Stapler 5 10(k-) Number K821994 5 10(k) Number K843034 and K892927, Ethicon and Ethicon Appliers 5 10(k) Number K83 0 503 DEPARTMENT OF HEALTH & HUMAN SERVICES…	ETHICON, Inc.	1984	—
*	K821994	Disposable Linear Stapler-(LSR) Summary page 1 …Linear Cutter: Vanguard reprocessed devices are substantially equivalent to Ethicon Linear Stapler 5 10(k-) Number K821994 5 10(k) Number K843034 and K892927, Ethicon and Ethicon Appliers 5 10(k) Number K83 0 503 DEPARTMENT OF HEAL…	ETHICON, Inc.	1982	—
*	K892927	Proximate Linear Cutter Thick Tissue Inst. Summary page 1 …ssed devices are substantially equivalent to Ethicon Linear Stapler 5 10(k-) Number K821994 5 10(k) Number K843034 and K892927, Ethicon and Ethicon Appliers 5 10(k) Number K83 0 503 DEPARTMENT OF HEALTH & HUMAN SERVICES…	ETHICON, Inc.	1989	—
*	K830503	Ligaclip Titanium Ligating Clip Summary page 1 …Linear Stapler 5 10(k-) Number K821994 5 10(k) Number K843034 and K892927, Ethicon and Ethicon Appliers 5 10(k) Number K83 0 503 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…	ETHICON, Inc.	1983	3

Also cleared against K843034: 3 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 4 ancestors has a recall of any class.
3 other devices also cite its predicate K843034.

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	—

What is it indicated for?

Cutters, Staplers and Appliers are indicated for resection, transection or ligation of

tissue in abdominal, gynecological, pediatric and thoracic applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032973 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032973: Reprocessed Disposable Cutters, Staplers and Appliers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032973

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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