510(k) · Cleared
ClearedReach Surgical Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reach Surgical, Inc. · GDW Staple, Implantable
Cleared on May 23, 2012 as substantially equivalent to K090821 (Frankenman International Limited, 2009) and 1 other predicate after a 124-day review. Its family tree reaches back 5 generations to 1994. 6 of the 35 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- May 23, 2012
- Review
- 124 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940967 (1994). 17 ancestors in all, the oldest K801590 (1980). 17 later devices descend from it, 6 citing it directly. 6 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 4 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- 3 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- 2 generations backK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- 1 generation backK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- This deviceK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK141367 LS Series Linear Stapler and Reloads, CLC Series Curved Linear…Touchstone International Medical Science Co., Ltd. · 2014
- Descendant · 2 generations on · 5 of its ownK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK182380 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK201882 AEON Endoscopic StaplerLexington Medical, Inc. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081146 Echelon Endoscopic Linear Cutters (Articulating…direct predicate · 2008
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…2 generations back · 2005
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…2 generations back · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…2 generations back · 1999
Most influential descendants
Showing 5 of 17 · See all- K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · cites it directly14descendants
- K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd. · 2014 · cites it directly7descendants
- K173443AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 2 generations on5descendants
- K182380AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 3 generations on4descendants
- K201882AEON Endoscopic StaplerLexington Medical, Inc. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −4 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| −3 | 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 |
| −1 | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| 0 (this device) | K120179 | Reach Surgical Staplers | Reach Surgical, Inc. | 2012 | — |
| +1 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
| +1 | K141367 | LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and… | Touchstone International Medical Science Co., Ltd. | 2014 | — |
| +2 | K173443 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018 | — |
| +3 | K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018 | — |
| +4 | K201882 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 1 |
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
6 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Summary page 3…11-2. Additional Information - Attachment 11 510(k) Summary 5. Predicate Device Identification 510(k) Number: K090821I Product Name: ChexiM Single Use Curved Intraluminal Circular Staipler ChexiM Single Use Reloadlable Linear Stapler an… | 2009 |
| * | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight)Summary page 3…or Rectal Prolaps and Hemorrhoids Chex'sM Linear Cutter Disposable Reloadlable Stapler Manufacturer: Frankman International Limited 5 10O(k) Number: KO081146 Predicate Device Name: Echelon Endoscopic Linear Cutters (Articulating and Straight) Manufacturer: Ethicon Endo-Surge… | 2008 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear… | 2013 | 14 |
| K141367 | LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC… | 2014 | 7 |
| K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers… | 2022 | 0 |
| K192566 | Reach and CQ'ENCE Circular Staplers | 2019 | 0 |
| K161905 | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable… | 2016 | 0 |
| K130738 | Endoscopic Linear Cutting Staplers with Single Use Loading Units | 2013 | 0 |
Has anything in its family been recalled? (6 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.
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon Endo-Surgery, Inc. · 2003 · 2 generations back · ◆ 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 8 of the 17 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K131511 (Changzhou Sinolinks Medical Innovation Co., Ltd., 2013) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K090821.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Circular Staplers with Staples have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The Linear Staplers with Single Use Loading Units have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Procedure Sets for Prolapse and Hemorrhoids have application for general…
Read the full statement (133 words)
The Circular Staplers with Staples have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Linear Staplers with Single Use Loading Units have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Procedure Sets for Prolapse and Hemorrhoids have application for general surgical treatment of hemorrhoids.
The Endoscopic Linear Cutting Staplers with Single Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Linear Cutting Staplers with Single Use Loading Units have application in abdominal, gynecological, thoracic and pediatric surgery transeclion, resection, and the creation of anastormoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120179: Reach Surgical Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120179
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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