EasyPPHTM Hemorrhoidal Stapler for Single Use
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183477 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 EasyPPHTM Hemorrhoidal Stapler for Single Use is a medical device designed for the treatment of hemorrhoids. It is a stapler that is intended to be used once and then discarded.
This device is supplied as a single-use item and is not intended for reuse. It is regulated under FDA 510K clearance with product code GDW. The device is manufactured by Ezisurg Medical Co., Ltd. in Shanghai, China.
Frequently asked questions
What is the EasyPPHTM Hemorrhoidal Stapler used for?
The EasyPPHTM Hemorrhoidal Stapler is a medical device designed specifically for the treatment of hemorrhoids. It is intended to be used once and then discarded, ensuring sterility and safety for each procedure.
Is the EasyPPHTM Hemorrhoidal Stapler reusable?
No, the EasyPPHTM Hemorrhoidal Stapler is supplied as a single-use item and is not intended for reuse. This design helps prevent cross-contamination and ensures optimal performance for each procedure.
What is the regulatory status of the EasyPPHTM Hemorrhoidal Stapler?
The EasyPPHTM Hemorrhoidal Stapler is regulated under FDA 510K clearance with product code GDW. It received FDA clearance on February 11, 2019, as substantially equivalent to predicate devices.
Who manufactures the EasyPPHTM Hemorrhoidal Stapler?
The EasyPPHTM Hemorrhoidal Stapler is manufactured by Ezisurg Medical Co., Ltd. located in Shanghai, China. The company is responsible for producing this single-use medical device for hemorrhoid treatment.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183477 | Class II | Active |
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Manufacturer
- Manufacturer
- Ezisurg Medical Co., Ltd.
Sources (1)
- FDA 510(k) K183477 24 fields · synced Sep 23, 2026