510(k) · Cleared
ClearedFrankenman Surgical Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Frankenman Medical Equipment Co., Ltd. · GDW Staple, Implantable
Cleared on Jun 29, 2010 as substantially equivalent to K090821 (Frankenman International Limited, 2009) and 2 other predicates after a 43-day review. Its family tree reaches back 5 generations to 1994. 5 of the 16 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 29, 2010
- Review
- 43 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K940967 (1994). 14 ancestors in all, the oldest K801590 (1980). 1 later device descends from it, 1 citing it directly. 5 of the 16 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 deviceK101378 Frankenman Surgical StaplersSuzhou Frankenman Medical Equipment Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK133499 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…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
- K983536 Proximate Curved and Straight Intraluminal…3 generations back · 1998
Most influential descendants
Showing 1 of 1 · See all- K133499Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal…Suzhou Beinuo Medical Equipment Co., Ltd. · 2014 · cites it directly0descendants
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) | K101378 | Frankenman Surgical Staplers | Suzhou Frankenman Medical Equipment Co., Ltd. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Summary page 3…Single Use Circular ChexTM Single Use Circular raennTM Stapler for Rectal Stapler for Rectal Prolapse and Intrnational Lmtd K090821 Prolapse andHeorodInentoaLitd HemorrhoidsHeorid Disposable Reloadable ChexT m Single Use Reloadlable Fr… | 2009 |
| * | K920752 | Endopath Ils Endoscopic Circular StaplerSummary page 4…aluminal Circular Stapler International Limited K002 Canal Staplers Endlopath ILS Endloscopic Ethicon K920752 Circular Stapler Single Use Circular Ce T igeUeCrua Stapler for Rectal Staper… | 1992 |
| Kept off the family tree | K091002 | Chex Single Use Reloadable Linear Stapler and Reloads Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K822345 | Disposable Linear Stapler (LSF)Summary page 4…apler and Linear Stapler and Reloads International Limited K082 Reloads Disposable Linear Stapler (LSF) Ethicon K822345 Disposable Reloadlable ChexTm Linear Cutter Disposable FrankenmanTm Linear Cutter Stapler Reloadabl… | 1982 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133499 | Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal… | 2014 | 0 |
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 · 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
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 14 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K133499 (Suzhou Beinuo Medical Equipment Co., Ltd., 2014) has gone furthest, with 0 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. 2010, 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?
Frankenman Staplers are indicated as follows: Disposable Alimentary Canal Stapler The Frankenman Disposable Alimentary Canal 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. Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid The Frankenman Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler…
Read the full statement (167 words)
Frankenman Staplers are indicated as follows:
Disposable Alimentary Canal Stapler
The Frankenman Disposable Alimentary Canal 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.
Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid
The Frankenman 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.
Disposable Reloadable Linear Stapler and Reloads
The Frankenman Disposable Reloadable Linear Stapler (and Reloads) is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Disposable Reloadable Linear Cutter Stapler and Reloads
The Frankenman Disposable Reloadlable Linear Cutter Stapler (and Reloads) 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/K101378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101378: Frankenman Surgical Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101378
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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