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K Number
K955168
Device Name
SURGICAL CUTTER
Manufacturer
PROMEX, INC.
Date Cleared
1996-01-22

(70 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Surgical Cutter

AI/ML Overview

I am sorry, but the provided text from the FDA letter about device K955168 only addresses regulatory information and does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it pertains to the device's technical or clinical performance. The document is strictly a regulatory communication regarding substantial equivalence. Therefore, I cannot fulfill your request based on the given input.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.