510(k) · Cleared
ClearedDisposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · GDW Staple, Implantable
Cleared on May 27, 2021 as substantially equivalent to K103470 (B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., 2011) and 1 other predicate after a 345-day review. Its family tree reaches back 10 generations to 1985. 4 of the 37 devices in its family, counting itself, have a Class I recall.
- Decided
- May 27, 2021
- Review
- 345 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K842066 (1985). 36 ancestors in all, the oldest K801590 (1980). No later device cites it as a predicate yet. 4 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations between
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 1 generation backK142577 PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2015
- This deviceK201639 Disposable Circular Staple, Disposable Hemorrhoidal Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 7 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 6 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 5 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 1 generation backK142577 PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2015
- This deviceK201639 Disposable Circular Staple, Disposable Hemorrhoidal Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −9 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −7 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −6 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −5 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −2 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −1 | K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015 | — |
| 0 (this device) | K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear… | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 1 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 1 |
| 1999 | 2 | 1 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 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.
4 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 |
|---|---|---|---|
| * | K103470 | Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal…Summary page 6…cknesses. It may be reloaded and fired up to 8 times in a single procedure. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K103470 Product Name: PANTHER Group of Surgical Staplers Predicate Device 2 510(k) Number: K142577 Product Name: Pa… | 2011 |
| * | K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsSummary page 6…edicate Devices Predicate Device 1 510(k) Number: K103470 Product Name: PANTHER Group of Surgical Staplers Predicate Device 2 510(k) Number: K142577 Product Name: Panther Endo Linear Cutter Staplers with Single Use Loading Unit 6. Non-Clinical Test Conclusion No… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K030411Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Ethicon Endo-Surgery, Inc. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 5 generations back · ◆ in the 1994 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 36 ancestors have a recall of any class; 4 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. 2021, 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 Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease. The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or…
Read the full statement (112 words)
The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease.
The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201639 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201639: Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201639
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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