510(k) · Cleared
ClearedPanther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal Circular Stapler; Panther Linear Stap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · GDW Staple, Implantable
Cleared on Jan 11, 2011 as substantially equivalent to K062850 (United States Surgical, A Division of Tyco Healthc, 2006) and 3 other predicates after a 46-day review. Its family tree reaches back 4 generations to 1994. 4 of the 10 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 11, 2011
- Review
- 46 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K940967 (1994). 8 ancestors in all, the oldest K801590 (1980). 1 later device descends from it, 1 citing it directly. 4 of the 10 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 backK030411 Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- This deviceK103470 Panther Group of Surgical Includes: Oanther Circular Stapler…B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK201639 Disposable Circular Staple, Disposable Hemorrhoidal Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021 · cites it directly0descendants
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 | K030411 | Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| 0 (this device) | K103470 | Panther Group of Surgical Includes: Oanther Circular Stapler; Panther… | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2011 | — |
| +1 | 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 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 15.0 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062850 | Autosuture Circular Eea Surgical StaplersSummary page 1…Number PANTHER Autosuturem EEATMI surgical United States K062850 Circular stapler Stapler Surgical Corp.… | 2006 |
| * | K030411 | Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Summary page 1…(USSC) PANTHER PROXIMATE PPH Hemorrhoidal Ethicon K(030411 Hemorrhoidal Circular Stapler and Accessories Endo-Surgery, Inc Circular Stapler PANTHER… | 2003 |
| * | K905106 | Auto Suture (R) TA Premium (TM) Urology StaplerSummary page 1…cular Stapler and Accessories Endo-Surgery, Inc Circular Stapler PANTHER AUTO SUTURE(R) TA United States K905106 Linear Stapler PREMIUM(TM)UOLG Surgical Corn. STAPLER… | 1991 |
| * | K801590 | Auto Suture Disposable Gia Surg. StaplerSummary page 1…. STAPLER (USSC) PANTHER AUTO SUTURE DISPOSABLE United States K801 590 Linear Cutter GIA SURG STAPLER Surgical Corn. Stapler ______________… | 1980 |
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 |
|---|---|---|---|
| K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler… | 2021 | 0 |
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 · 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
- 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 17 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 8 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K201639 (Beijing Biosis Healing Biolog Ical Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K062850.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Panther Circular staplers and accessories have 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 PANTHER Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The PANTHER Linear Stapler can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The PANTHER Linear Cutter Stapler can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103470: Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal Circular Stapler; Panther Linear Stap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103470
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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