PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142577 FDA 510(k)
- FDA Product Code
- GDW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4750 FDA 510(k)
- Regulation Number
- 878.4750 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Panther Endo Linear Cutter Staplers with Single-Use Loading Units are endoscopic stapling devices designed for surgical applications. These devices are intended to simultaneously cut and staple tissue, facilitating precise and controlled closure of anatomical structures during minimally invasive procedures.
These staplers are supplied as single-use devices, ensuring sterility and reducing cross-contamination risks. They are classified as Class II medical devices under FDA regulations (878.4750) and are authorized via FDA 510K clearance and MDR compliance. Various sizes and configurations are available, as indicated by the listed FEI numbers, and are intended for use in general and plastic surgery settings.
Frequently asked questions
Are the Panther Endo Linear Cutter Staplers designed for reuse in multiple procedures, or are they intended for single-use only?
The Panther Endo Linear Cutter Staplers are explicitly designed as single-use devices, ensuring sterility and eliminating cross-contamination risks. This aligns with their intended surgical application in minimally invasive procedures, where single-use reduces infection hazards and operational complexity.
What surgical specialties are these staplers primarily intended for, and how does that influence their design?
These staplers are intended for general and plastic surgery, as noted in their advisory committee description. Their design prioritizes precision and controlled tissue closure, which is critical for both general surgical applications (e.g., gastrointestinal anastomoses) and plastic surgery (e.g., reconstructive procedures requiring delicate tissue handling).
How many different sizes or configurations are available for the Panther Endo Linear Cutter Staplers, and how can I identify them?
The device comes in multiple sizes/configurations, each identified by unique FEI numbers (e.g., 3011052945, 3003495548, etc.). These numbers correspond to specific staple lengths, widths, or firing mechanisms, allowing surgeons to select the appropriate size for their anatomical needs. The full list is available in the regulatory records.
What regulatory pathways have been followed to authorize these staplers, and what does that mean for their use in clinical settings?
The Panther Endo Linear Cutter Staplers have undergone FDA 510(k) clearance and MDR compliance, confirming they meet U.S. and EU regulatory standards for safety and performance. This authorization ensures they can be legally marketed and used in clinical settings where these pathways apply, though actual use depends on local healthcare provider compliance with institutional protocols.
How should these staplers be stored to maintain their integrity before use, given they are single-use?
Since these staplers are single-use and sterile, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging protects against contamination and ensures sterility until the first use, as required for endoscopic surgical instruments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K142577 | Class II | Active |
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Manufacturer
- Manufacturer
- B. J. ZH. F. Panther Medical Equipment Co., Ltd.
- FDA Applicant
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Sources (2)
- FDA 510(k) K142577 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026