510(k) · Cleared
ClearedPANTHER Cutter Stapler
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 Nov 12, 2015 as substantially equivalent to K091322 (Ethicon Endo-Surgery, Inc., 2009) after a 59-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Nov 12, 2015
- Review
- 59 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K843034 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK843034 Disposable Linear CutterETHICON, Inc. · 1984
- 3 generations backK040038 Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved…Ethicon Endo-Surgery, Inc. · 2004
- 2 generations backK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
- 1 generation backK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009
- This deviceK152618 PANTHER Cutter StaplerB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K843034 | Disposable Linear Cutter | ETHICON, Inc. | 1984 | — |
| −3 | K040038 | Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models… | Ethicon Endo-Surgery, Inc. | 2004 | — |
| −2 | K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40G | Ethicon Endo-Surgery, LLC | 2007 | — |
| −1 | K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G | Ethicon Endo-Surgery, Inc. | 2009 | — |
| 0 (this device) | K152618 | PANTHER Cutter Stapler | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2006 | 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.
Planning a device in GDW? 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? (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 |
|---|---|---|---|
| * | K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GSummary page 4…urgical; Classification: II; Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4880 Review Panel: General & Plastic Surgery Predicate Devices 510(k) Number: K091322 Product Name: CONTOURTM Curved Cutter Stapler and Reloads Device Description The proposed device, PANTHER Cutter Stapler, is… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K091322.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152618: PANTHER Cutter Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152618
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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