510(k) · Cleared
ClearedChex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frankenman International Limited · GDW Staple, Implantable
Cleared on Jun 10, 2009 as substantially equivalent to K920752 (ETHICON, Inc., 1992) and 10 other predicates after a 76-day review. Its family tree reaches back 4 generations to 1994. 5 of the 35 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.
- Decided
- Jun 10, 2009
- Review
- 76 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 4 generations to K940967 (1994). 13 ancestors in all, the oldest K801590 (1980). 21 later devices descend from it, 3 citing it directly. 5 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 3 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- 2 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- 1 generation backK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- This deviceK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- Descendant · cites it directly · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
- Descendant · 2 generations on · 7 of its ownK141367 LS Series Linear Stapler and Reloads, CLC Series Curved Linear…Touchstone International Medical Science Co., Ltd. · 2014
- Descendant · 3 generations on · 5 of its ownK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- Descendant · 4 generations on · 4 of its ownK182380 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…direct predicate · 2005
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…direct predicate · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…direct predicate · 1999
- K983536 Proximate Curved and Straight Intraluminal…2 generations back · 1998
Most influential descendants
Showing 5 of 21 · See all- K120179Reach Surgical StaplersReach Surgical, Inc. · 2012 · cites it directly17descendants
- K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 2 generations on14descendants
- K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd. · 2014 · 2 generations on7descendants
- K173443AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 3 generations on5descendants
- K182380AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −3 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| −2 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| −1 | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| 0 (this device) | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| +1 | K120179 | Reach Surgical Staplers | Reach Surgical, Inc. | 2012 | — |
| +2 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
| +2 | K141367 | LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and… | Touchstone International Medical Science Co., Ltd. | 2014 | — |
| +3 | K173443 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018 | — |
| +4 | K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018 | — |
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 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 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.
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? (12)
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 |
|---|---|---|---|
| * | K920752 | Endopath Ils Endoscopic Circular StaplerSummary page 1…are substantially equivalent to: 4 ZA'4 Endlopath ILS Endloscopic Ethicon K920752 CircularStapler _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ CheX TM… | 1992 |
| * | K024275 | Auto Suture Premium Plus Ceea Disposable StaplerSummary page 1…ers United StatesK625 T M Circular Stapler Autostu Premium Plus Surgical Corp. K024275 uoE Dsuure e tales(USSC) K020804… | 2003 |
| * | K020804 | Auto Suture Premium Plus Ceea Disposable StaplerSummary page 1…mium Plus Surgical Corp. K024275 uoE Dsuure e tales(USSC) K020804 CEEA Disposable StaplersK001895 CheXTM Single… | 2002 |
| * | K001895 | Auto Suture Premium Plus Ceea Disposable StaplerSummary page 1…es(USSC) K020804 CEEA Disposable StaplersK001895 CheXTM Single Use Circular Stapler for Ethicon Endlo- Rectal Prolapse and… | 2000 |
| * | K051301 | Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesSummary page 1…apler for Ethicon Endlo- Rectal Prolapse and Surgery, Inc. K051301 Hemorrhoids Proximate PPH Hemorrhoidal_________________ Circular Stapler and… | 2005 |
| * | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesSummary page 2…NNu-mbe~r Hemorrhoidal Circular Stapler K991030 and Accessories Hemorrhoidal Circular Stapler… | 1999 |
| * | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Summary page 2…K991030 and Accessories Hemorrhoidal Circular Stapler K030925 and Accessories Chex Single Use TM Disposable Linear Stapler… | 2003 |
| * | K822345 | Disposable Linear Stapler (LSF)Summary page 2…K030925 and Accessories Chex Single Use TM Disposable Linear Stapler Ethicon K822345 Reloadable Linear (LSF) Stapler and Reloads Auto Suture TM TA premium TM USSC K9051… | 1982 |
| * | K905106 | Auto Suture (R) TA Premium (TM) Urology StaplerSummary page 2…r Ethicon K822345 Reloadable Linear (LSF) Stapler and Reloads Auto Suture TM TA premium TM USSC K905106 Auto Suture Disposable TM Chex Linear TM… | 1991 |
| * | K801590 | Auto Suture Disposable Gia Surg. StaplerSummary page 2…Suture Disposable TM Chex Linear TM GATSugcltaerUSSC K801590 Cutter DsposableGIA Surgical Stapler TM RutteroaDabesapler Proximate Linear Cutters and… | 1980 |
| * | K951546 | Endopath and Proximate Linear Cutters and StaplersSummary page 2…TM RutteroaDabesapler Proximate Linear Cutters and Ethicon Endo- Reloadable Stapler Stapler (not Endopath) Surgery, Inc. K951546 4. Intended Use The Chex Family of Staplers and there intended uses are as follows: Single Use Cur… | 1995 |
| * | — | Auto Suture Circular Surgical Staplers Named without a submission number |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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.
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- 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 · 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 15 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 13 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K120179 (Reach Surgical, Inc., 2012) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K920752.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Chex Family of Staplers and there intended uses are as follows: 1. Single Use Curved Intraluminal Circular Stapler The CHEX TM Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques. 2. Circular Stapler for Rectal Prolapse and Hemorrhoid The CHEX TM Single Use Circular Stapler for Rectal Prolapse and…
Read the full statement (179 words)
The Chex Family of Staplers and there intended uses are as follows:
1. Single Use Curved Intraluminal Circular Stapler
The CHEX TM Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.
2. Circular Stapler for Rectal Prolapse and Hemorrhoid
The CHEX TM Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.
3. Single Use Reloadable Linear Stapler
The CHEX TM Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
4. Single Use Reloadable Linear Cutter Stapler
The CHEX TM Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090821: Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090821
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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