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K Number
K020804
Device Name
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
Manufacturer
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Date Cleared
2002-11-19

(252 days)

Product Code
GDW
Regulation Number
878.4750
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Auto Suture* Premium Plus CEEA* Disposable Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Device Description

The Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler is a single patient use device which places a double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis.

AI/ML Overview

This looks like a 510(k) premarket notification for a surgical stapler, which is a physical medical device and not an AI/ML powered device. As such, the requested information (acceptance criteria and study details related to AI/ML device performance) is not applicable to this submission.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluation.

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.