510(k) · Cleared

Recalled · Class I · 2012

Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03

K030411510(k) TraditionalCleared Mar 20, 200341-day reviewClass II21 CFR 878.4750Recalls 1 (1 Class I)

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

Ethicon Endo-Surgery, Inc. · GDW Staple, Implantable

Cleared on Mar 20, 2003 as substantially equivalent to K991030 (Ethicon Endo-Surgery, Inc., 1999) after a 41-day review. Its family tree reaches back 3 generations to 1994. 4 of the 10 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Mar 20, 2003
Review: 41 days
Class: Class II
Product code: GDW
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 3 generations to K940967 (1994). 6 later devices descend from it, 4 citing it directly. 4 of the 10 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
2 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
1 generation backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
This deviceK030411 Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003
Descendant · cites it directly · 1 of its ownK162707 Single Use Circular Stapler, Single Use Hemorrhoidal Circular…Golden Stapler Surgical Co., Ltd. · 2017
Descendant · cites it directly · 1 of its ownK103470 Panther Group of Surgical Includes: Oanther Circular Stapler…B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2011
Descendant · 2 generations on · 0 of its ownK201639 Disposable Circular Staple, Disposable Hemorrhoidal Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
Descendant · 2 generations on · 0 of its ownK200320 Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus…M/s. Meril Endo Surgery Private Limited. · 2021
Descendant · cites it directly · 0 of its ownK183477 easyPPHTM Hemorrhoidal Stapler for Single UseEzisurg Medical Co., Ltd. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011high 2 (2017) · low 0 (2012)2026

Class I recalls in this family

K991030 Proximate HCS Hemorrhoidal Circular Stapler and…direct predicate · 1999
K983536 Proximate Curved and Straight Intraluminal…2 generations back · 1998
K940967 Modified Endopath Ils3 generations back · 1994

Most influential descendants

Showing 5 of 6 · See all

K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd. · 2017 · cites it directly1descendant
K103470Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal…B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2011 · cites it directly1descendant
K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021 · 2 generations on0descendants
K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited. · 2021 · 2 generations on0descendants
K183477easyPPHTM Hemorrhoidal Stapler for Single UseEzisurg Medical Co., Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K940967	Modified Endopath Ils	Ethicon Endo-Surgery, Inc.	1994	Class I
−2	K983536	Proximate Curved and Straight Intraluminal Staplers	Ethicon Endo-Surgery, Inc.	1998	Class I
−1	K991030	Proximate HCS Hemorrhoidal Circular Stapler and Accessories	Ethicon Endo-Surgery, Inc.	1999	Class I
0 (this device)	K030411	Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03	Ethicon Endo-Surgery, Inc.	2003	—
+1	K162707	Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single…	Golden Stapler Surgical Co., Ltd.	2017	—
+1	K103470	Panther Group of Surgical Includes: Oanther Circular Stapler; Panther…	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.	2011	—
+2	K201639	Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear…	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	2021	—
+2	K200320	Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal…	M/s. Meril Endo Surgery Private Limited.	2021	—
+1	K183477	easyPPHTM Hemorrhoidal Stapler for Single Use	Ezisurg Medical Co., Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2017	2	0
2019	1	0
2021	2	0

FIG. 1 — Lineage of K030411, 1994–2021Source: 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 15.0 · 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? (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
*	K991030	Proximate HCS Hemorrhoidal Circular Stapler and Accessories	Ethicon Endo-Surgery, Inc.	1999	Class I

Also cleared against K991030: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K162707	Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…	Golden Stapler Surgical Co., Ltd.	2017	1
K103470	Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal…	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.	2011	1
K183477	easyPPHTM Hemorrhoidal Stapler for Single Use	Ezisurg Medical Co., Ltd.	2019	0
K162710	Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…	Tgs Medical Co., Ltd.	2017	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 3, 2012	Class I	Z-0057-2013	Process change control	Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Stapler Procedure Set (STR10) due to…

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.

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

What does this lineage say?

The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
3 of the 3 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K162707 (Golden Stapler Surgical Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K991030.

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?

The PROXIMATE? PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030411: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030411

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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