Signia Stapler (with new software)
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K201672 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 device is a staple, implantable, used in general and plastic surgery procedures. It is a stapler system designed for resection and transection of tissue.
It is supplied as a power tool for use in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery. The device has received FDA 510(k) clearance under k-number K201672 and is classified as a Class II medical device.
Frequently asked questions
What is the Signia Stapler (with new software) used for?
The Signia Stapler (with new software) is a staple, implantable device designed for resection and transection of tissue during general and plastic surgery procedures. It functions as a power tool for use in open or minimally invasive surgical settings, enabling precise tissue cutting and stapling in abdominal, gynecologic, pediatric, and thoracic operations.
How is the Signia Stapler (with new software) supplied and is it reusable?
The device is supplied as a power tool system intended for use in surgical procedures. Based on its classification as an implantable staple device and its description as a stapler system for resection and transection, it is intended for single-use only to ensure sterility and prevent cross-contamination; reuse is not indicated or supported by the provided data.
What regulatory pathway was used for the Signia Stapler (with new software)?
The Signia Stapler (with new software) received FDA 510(k) clearance under k-number K201672, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance pathway is used for moderate-risk Class II medical devices, which aligns with its classification as a Class II device under regulation number 878.4750.
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: Signia™ stapling system - Medtronic, Signia™ Stapling System | Medtronic (NZ), COVIDIEN SIGNIA STAPLING SYSTEM USER MANUAL Pdf Download, Signia Stapler (with new software) (K201672) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201672 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K201672 24 fields · synced Sep 25, 2026