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Snowden Pencer Laparoscopic Ergonomic Reposable Scissors

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113407

by Carefusion 2200, Inc.

Identifiers

510(k) Number
K113407 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Snowden Pencer Laparoscopic Ergonomic Reposable Scissors are a laparoscopic surgical instrument designed for use in minimally invasive procedures. The device consists of a reusable handle that connects to disposable scissor tips, allowing for modular use in laparoscopic surgery.

The scissors are supplied as a reposable system with a reusable handle and disposable tips, intended for use in laparoscopic procedures. They are provided non-sterile and require sterilization prior to use, and are authorized under FDA 510(k) clearance K113407 with product code GEI.

Frequently asked questions

What is the Snowden Pencer Laparoscopic Ergonomic Reposable Scissors intended for?

The device is designed for use in minimally invasive laparoscopic procedures, where it functions as a surgical scissor instrument with a reusable handle and disposable tips to enable modular use during surgery.

How is the Snowden Pencer Laparoscopic Ergonomic Reposable Scissors supplied and prepared for use?

The scissors are supplied as a reposable system with a reusable handle and disposable tips, provided non-sterile, and must be sterilized by the user prior to each use to ensure safe application in laparoscopic procedures.

What regulatory authorization does the Snowden Pencer Laparoscopic Ergonomic Reposable Scissors have?

The device is authorized under FDA 510(k) clearance K113407 with product code GEI, indicating it was found substantially equivalent to a legally marketed predicate device through a traditional review process.

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: Purchase Reposable/Disposable Scissors | Shop STERIS, Snowden Pencer™ Ergonomic Modular Laparoscopic Instruments, Laparoscopic Surgical Instruments for Precision | STERIS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Carefusion 2200, Inc.

Sources (1)

  • FDA 510(k) K113407 24 fields · synced Sep 23, 2026