Proximate HCS Hemorrhoidal Circular Stapler and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K991030 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 Proximate HCS Hemorrhoidal Circular Stapler and Accessories is a 33 mm diameter surgical instrument used in the anal canal for the general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue. The device facilitates the surgical treatment of hemorrhoidal disease throughout the anal canal.
The device is supplied as part of a kit and is intended for single-use. It is a Class II medical device with product code GDW and has received FDA 510(k) clearance with K number K991030. The device is authorized for use in general and plastic surgery procedures.
Frequently asked questions
What is the Proximate HCS Hemorrhoidal Circular Stapler used for?
The Proximate HCS Hemorrhoidal Circular Stapler is a 33mm diameter surgical instrument used in the anal canal for the general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue, particularly for hemorrhoidal disease treatment.
How is the Proximate HCS Hemorrhoidal Circular Stapler supplied?
The device is supplied as part of a kit and is intended for single-use. It is a Class II medical device with product code GDW and has received FDA 510(k) clearance with K number K991030.
Is the Proximate HCS Hemorrhoidal Circular Stapler reusable?
No, the Proximate HCS Hemorrhoidal Circular Stapler is intended for single-use only. It should not be reused on multiple patients as this could compromise sterility and device performance.
What surgical procedures is the Proximate HCS Hemorrhoidal Circular Stapler authorized for?
The device is authorized for use in general and plastic surgery procedures for the treatment of hemorrhoidal disease throughout the anal canal by means of transanal stapling and resection of mucosal and musculomucosal tissue.
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. Sources consulted: PDF PROXIMATE@ HCS Hemorrhoidal Circular Stapler and Accessories (PPHO1), Proximate Hcs Hemorrhoidal Circular Stapler and Accessories (K991030 ..., Proximate Hcs Hemorrhoidal Circular Stapler and Accessories, Model ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991030 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K991030 24 fields · synced Sep 25, 2026