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Proximate Reloadable Articulating Linear Stapler

FDA 510(k)

Class II (US FDA 510(k))

510(k) K932476

by Ethicon Endo-Surgery, Inc.

Identifiers

510(k) Number
K932476 FDA 510(k)
FDA Product Code
GAG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4740 FDA 510(k)
Regulation Number
878.4740 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Proximate Reloadable Articulating Linear Stapler is a mechanical surgical stapling device designed to provide dependable staple formation. It is part of a linear cutter platform that offers multiple device lengths and reload options to meet various patient and procedure needs.

This device is supplied as a reloadable instrument with multiple size options and is intended for use in general hospital settings. It received FDA 510(k) clearance with product code GAG and is classified as a Class 2 device. The stapler features a mechanism that prevents a used reload from being fired again.

Frequently asked questions

What is the Proximate Reloadable Articulating Linear Stapler used for?

This device is a mechanical surgical stapling device designed to provide dependable staple formation as part of a linear cutter platform with multiple device lengths and reload options for various patient and procedure needs in general hospital settings.

How is the Proximate Reloadable Articulating Linear Stapler supplied?

The device is supplied as a reloadable instrument with multiple size options to accommodate different surgical requirements and patient anatomies.

Is the Proximate Reloadable Articulating Linear Stapler single-use or reusable?

The device is reloadable, meaning the main instrument can be reused with different reload units, but each reload unit is designed for single use as it features a mechanism that prevents a used reload from being fired again.

What regulatory route has the Proximate Reloadable Articulating Linear Stapler taken?

The device received FDA 510(k) clearance with product code GAG and is classified as a Class 2 device, indicating it has been determined to be substantially equivalent to predicate devices already on the market.

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: ETHICON PROXIMATE™ Linear Cutters | J&J MedTech US, PDF ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers 510(k) Summary ..., Proximate Reloadable Articulating Linear Stapler, K932476 FDA 510(k) - PROXIMATE RELOADABLE ARTICULATING LINEA...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA 510(k) K932476 24 fields · synced Sep 19, 2026