510(k) · Cleared
ClearedSuzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal Circular Staplers for Single Use, Linea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Beinuo Medical Equipment Co., Ltd. · GDW Staple, Implantable
Cleared on Jan 14, 2014 as substantially equivalent to K101378 (Suzhou Frankenman Medical Equipment Co., Ltd., 2010) after a 61-day review. Its family tree reaches back 6 generations to 1994. 5 of the 16 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 14, 2014
- Review
- 61 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K940967 (1994). 15 ancestors in all, the oldest K801590 (1980). No later device cites it as a predicate yet. 5 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 5 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- 4 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- 3 generations backK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- 2 generations backK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- 1 generation backK101378 Frankenman Surgical StaplersSuzhou Frankenman Medical Equipment Co., Ltd. · 2010
- This deviceK133499 Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use…Suzhou Beinuo Medical Equipment Co., Ltd. · 2014
Class I recalls in this family
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…3 generations back · 2005
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…3 generations back · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…3 generations back · 1999
- K983536 Proximate Curved and Straight Intraluminal…4 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −5 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| −4 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| −3 | 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 | — |
| −1 | K101378 | Frankenman Surgical Staplers | Suzhou Frankenman Medical Equipment Co., Ltd. | 2010 | — |
| 0 (this device) | K133499 | Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use… | Suzhou Beinuo Medical Equipment Co., Ltd. | 2014 | — |
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 |
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 15.1 · 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? (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 |
|---|---|---|---|
| * | K101378 | Frankenman Surgical StaplersSummary page 1…Device Class: Class 11 Classification Panel: General and Plastic Surgery S. Predicate Devices The Suzhou Frankenman Surgical Staplers (K101378) which includes: * Disposable Alimentary Canal Staplers; * Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 5 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 15 ancestors have a recall of any class; 5 have a Class I recall.
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?
Suzhou Beinuo surgical staplers are indicated for use as follows: -Circular Stapler for Single Use The Suzhou Beinuo Circular Stapler for Single Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses. * Hemorrhoidal Circular Stapler for Single Use The Suzhou Beinuo Hermorrhoidal Circular Stapler for Single Use is a Circular Stapler product, with…
Read the full statement (159 words)
Suzhou Beinuo surgical staplers are indicated for use as follows:
-Circular Stapler for Single Use
The Suzhou Beinuo Circular Stapler for Single Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses.
* Hemorrhoidal Circular Stapler for Single Use
The Suzhou Beinuo Hermorrhoidal Circular Stapler for Single Use is a Circular Stapler product, with accessories, that is indicated in anorectal surgical procedures for the treatment of hemorrhoids and anorectal wall defects.
* Linear Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Stapler and Reloads for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures.
* Linear Cutter Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Cutter Stapler and Reloads for Single Use (and reloads) is indicated for use in the resection, transection and anastomosis of tissue in gastrointestinal, gynecological, and thoracic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133499: Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal Circular Staplers for Single Use, Linea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133499
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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