510(k) · Cleared

Cleared

easyPPHTM Hemorrhoidal Stapler for Single Use

K183477510(k) TraditionalCleared Feb 11, 201956-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

Ezisurg Medical Co., Ltd. · GDW Staple, Implantable

Cleared on Feb 11, 2019 as substantially equivalent to K030411 (Ethicon Endo-Surgery, Inc., 2003) after a 56-day review. Its family tree reaches back 4 generations to 1994. 4 of the 5 devices in its family, counting itself, have a Class I recall.

Decided: Feb 11, 2019
Review: 56 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K940967 (1994). No later device cites it as a predicate yet. 4 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
3 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
2 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
1 generation backK030411 Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
This deviceK183477 easyPPHTM Hemorrhoidal Stapler for Single UseEzisurg Medical Co., Ltd. · 2019

Class I recalls in this family

K030411 Proximate PPH Hemorrhoidal Circular Stapler and…direct predicate · 2003
K991030 Proximate HCS Hemorrhoidal Circular Stapler and…2 generations back · 1999
K983536 Proximate Curved and Straight Intraluminal…3 generations back · 1998
K940967 Modified Endopath Ils4 generations back · 1994

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K940967	Modified Endopath Ils	Ethicon Endo-Surgery, Inc.	1994	Class I
−3	K983536	Proximate Curved and Straight Intraluminal Staplers	Ethicon Endo-Surgery, Inc.	1998	Class I
−2	K991030	Proximate HCS Hemorrhoidal Circular Stapler and Accessories	Ethicon Endo-Surgery, Inc.	1999	Class I
−1	K030411	Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03	Ethicon Endo-Surgery, Inc.	2003	Class I
0 (this device)	K183477	easyPPHTM Hemorrhoidal Stapler for Single Use	Ezisurg Medical Co., Ltd.	2019	—

FIG. 1 — Lineage of K183477, 1994–2019Source: 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.

4 devices in this family have a Class I recall. 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? (1)

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
*	K030411	Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03 Summary page 5 …s tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size. 5. Identification of Predicate Device 510(k) Number: K030411 Product Name: PROXIMATE®PPH Hemorrhoidal Circular Stapler and Accessories 6. Non-Clinical Test Conclusion Non cli…	Ethicon Endo-Surgery, Inc.	2003	Class I

Also cleared against K030411: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (4 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K030411Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Ethicon Endo-Surgery, Inc. · 2003 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 112 Class I recalls
K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 4 generations back · ◆ on the line of descent in FIG. 14 Class I recalls

What does this lineage say?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
4 of the 4 ancestors have a recall of any class; 4 have a Class I recall.
3 other devices also cite its predicate K030411.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal canal to perform surgical

treatment of hemorhoidal disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K183477 · printed Nov 5, 2026

Cite this page

510(k) Report. “K183477: easyPPHTM Hemorrhoidal Stapler for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183477

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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