510(k) Report

510(k) · Cleared

Recalled · Class I · 2018

Proximate PPH Hemorrhoidal Circular Stapler and Accessories

K051301510(k) TraditionalCleared Aug 30, 2005103-day reviewClass II21 CFR 878.4750Recalls 3 (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 Aug 30, 2005 after a 103-day review. The FDA summary names its predicate without a number. 1 of the 26 devices in its family, counting itself, has a Class I recall. 25 later devices descend from it. It has been recalled 3 times, including a Class I recall.

Decided
Aug 30, 2005
Review
103 days
Class
Class II
Product code
GDW
Recalls
3 (1 Class I)
Predicates
0

25 later devices descend from it, 4 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2009: 2 descendants cleared2017: 2 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2014: 3 descendants cleared2019: 1 descendant cleared2013: 2 descendants cleared2022: 1 descendant cleared2016: 2 descendants cleared2018: 2 descendants cleared2021: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK051301 Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005
  2. Descendant · cites it directly · 21 of its ownK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
  3. Descendant · 2 generations on · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
  4. Descendant · 3 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
  5. Descendant · 3 generations on · 7 of its ownK141367 LS Series Linear Stapler and Reloads, CLC Series Curved Linear…Touchstone International Medical Science Co., Ltd. · 2014
  6. Descendant · 4 generations on · 5 of its ownK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22011: 12012: 12013: 22014: 32016: 22017: 22018: 22019: 12020: 12021: 12022: 12023: 22024: 12025: 1
2009high 3 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 25 · See all
  • K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited · 2009 · cites it directly21descendants
  • K120179Reach Surgical StaplersReach Surgical, Inc. · 2012 · 2 generations on17descendants
  • K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 3 generations on14descendants
  • K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd. · 2014 · 3 generations on7descendants
  • K173443AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc.2005—
+1K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS…Frankenman International Limited2009—
+2K120179Reach Surgical StaplersReach Surgical, Inc.2012—
+3K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable…Changzhou Sinolinks Medical Innovation Co., Ltd.2013—
+3K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and…Touchstone International Medical Science Co., Ltd.2014—
+4K173443AEON Endoscopic StaplerLexington Medical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201110
201210
201320
201430
201620
201720
201820
201910
202010
202110
202210
202320
202410
202510
FIG. 1 — Lineage of K051301, 2005–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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

TypeNumberDeviceApplicantDecidedRecalls
*—PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories
Named without a submission number
—

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited200921
K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170
K103672Reusable PPH Circular Stapler Handle, PPH Circular Stapler Reload & Accessory SetEthicon Endo-Surgery, LLC20110
K083781Eea Hemorrhoid Stapler & AccessoriesSurgical Devices, A Global Business Unit Covidien20090

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 7, 2018Class IIZ-0696-2019Process controlHemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
Aug 3, 2012Class IZ-0057-2013Process change controlEthicon 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…
Apr 2, 2007Not classifiedZ-0980-2007OtherThe adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K090821 (Frankenman International Limited, 2009) has gone furthest, with 21 descendants 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

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
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

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

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.

More from Ethicon Endo-Surgery, Inc.

111 FDA decisions under this applicant name. See the company

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 20141 Class I recall
  • K111195Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
  • K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
  • K101520Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHEthicon Endo-Surgery, Inc. · 2010
  • K102632Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerEthicon Endo-Surgery, Inc. · 2010

Recent decisions in GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K051301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051301: Proximate PPH Hemorrhoidal Circular Stapler and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051301

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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