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K Number
K031951
Device Name
TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
Manufacturer
BAYLIS MEDICAL CO., INC.
Date Cleared
2003-09-11

(79 days)

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

The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs

Device Description

Transdiscal System

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a medical device (Transdiscal System), indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulatory class, and intended use, but it does not include detailed study results or performance metrics as requested in your prompt.

§ 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.