510(k) · Cleared
Recalled · Class I · 2019Proximate Curved and Straight Intraluminal Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GDW Staple, Implantable
Cleared on Dec 18, 1998 as substantially equivalent to K940967 (Ethicon Endo-Surgery, Inc., 1994) after a 70-day review. Its family tree reaches back 1 generation to 1994. 5 of the 43 devices in its family, counting itself, have a Class I recall. 41 later devices descend from it. It has been recalled 13 times, including 12 Class I recalls.
- Decided
- Dec 18, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 13 (12 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940967 (1994). 41 later devices descend from it, 9 citing it directly. 5 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- This deviceK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998
- Descendant · cites it directly · 30 of its ownK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- Descendant · 2 generations on · 22 of its ownK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 21 of its ownK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- Descendant · 3 generations on · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
- Descendant · 4 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 41 · See all- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · cites it directly30descendants
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon Endo-Surgery, Inc. · 2003 · 2 generations on22descendants
- K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited · 2009 · 2 generations on21descendants
- K120179Reach Surgical StaplersReach Surgical, Inc. · 2012 · 3 generations on17descendants
- K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| 0 (this device) | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | — |
| +1 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| +2 | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| +2 | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| +3 | K120179 | Reach Surgical Staplers | Reach Surgical, Inc. | 2012 | — |
| +4 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 1 |
| 2003 | 2 | 2 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
5 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
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 | Decided |
|---|---|---|---|
| * | K940967 | Modified Endopath IlsSummary page 1…sories Common Name: Circular Stapler Trade Name /Proprietary Name: PROXIMATE® Curved and Straight Intraluminal Staplers Legally Modified ENDOPATHP®ILS Circular Stapler (K940967). marketed device Device All device functions, scientific concepts, significant physical and performance description character… | 1994 |
What descends from it? (41)
See all 419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories Class I | 1999 | 30 |
| K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | 2018 | 2 |
| K050356 | Compression Anastomosis Ring (Car) | 2005 | 2 |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient… | 2017 | 1 |
| K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use | 2019 | 0 |
| K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular… | 2019 | 0 |
| K163523 | ECHELON CIRCULAR Powered Stapler | 2017 | 0 |
| K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient… | 2017 | 0 |
| K111195 | Valutrus Reusable Circular Stapler and Disposable Reloads | 2011 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2019 | Class I | Z-1272-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1267-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1274-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1269-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1277-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1276-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1270-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1278-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1273-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1275-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1268-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1271-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Oct 23, 2017 | Class II | Z-0672-2018 | Under Investigation by firm | There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples. |
The 5 latest of 13 recalls; the web page lists all.
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.
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K030411Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Ethicon Endo-Surgery, Inc. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon Endo-Surgery, Inc. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K991030 (Ethicon Endo-Surgery, Inc., 1999) has gone furthest, with 30 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 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® Curved and Straight Intraluminal Staplers have
application throughout the alimentary tract for end to end, end to side and side* to side anastomoses including application throughout the anal canal to
perform surgical treatment for hemorrhoidal disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983536: Proximate Curved and Straight Intraluminal Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983536
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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