510(k) · Cleared
ClearedCSC Series Intraluminal Stapler for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Touchstone International Medical Science Co., Ltd. · GDW Staple, Implantable
Cleared on Sep 26, 2014 as substantially equivalent to K131511 (Changzhou Sinolinks Medical Innovation Co., Ltd., 2013) and 1 other predicate after a 151-day review. Its family tree reaches back 7 generations to 1994. 6 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 26, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K940967 (1994). 25 ancestors in all, the oldest K801590 (1980). No later device cites it as a predicate yet. 6 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 6 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- 5 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- 4 generations backK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- 3 generations backK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- 2 generations backK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
- 1 generation backK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
- This deviceK141097 CSC Series Intraluminal Stapler for Single UseTouchstone International Medical Science Co., Ltd. · 2014
Class I recalls in this family
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…direct predicate · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…2 generations back · 1999
- K081146 Echelon Endoscopic Linear Cutters (Articulating…3 generations back · 2008
- K983536 Proximate Curved and Straight Intraluminal…3 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −6 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| −5 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| −4 | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| −3 | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | K141097 | CSC Series Intraluminal Stapler for Single Use | Touchstone International Medical Science Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 1 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 1 |
| 2009 | 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 15.0 · 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? (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 |
|---|---|---|---|
| * | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Summary page 10…Section 3 510(k) Summary 4. Predicate Device Identification 4.1 Predicate Device for Disposable Circular Stapler 510(k) Number: K131511 Product Name: Disposable Circular Stapler Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd. 4.2 Pr… | 2013 |
| * | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Summary page 10…: Disposable Hemorrhoidal Stapler Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd. 4.3 Predicate Device for PROXIMATE® HCS 510(k) Number: K030925 Product Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories(PPH01) Manufacturer: Ethicon Endo-Surgery, I… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon 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
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of 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
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- 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 20 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 9 of the 25 ancestors have a recall of any class; 6 have a Class I recall.
- 3 other devices also cite its predicate K131511.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CSC Series Intraluminal Stapler for Single Use 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 PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.
The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomuscular tissue.
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/K141097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141097: CSC Series Intraluminal 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/K141097
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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