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K Number
K050499
Device Name
PROBLOC, HN SERIES AND PROLONG, PL SERIES
Manufacturer
LIFE-TECH, INC.
Date Cleared
2005-05-17

(78 days)

Product Code
BSP
Regulation Number
868.5150
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block.

Device Description

Not Found

AI/ML Overview

This document does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) substantial equivalence determination letter from the FDA for a device named "ProBloc" and "Prolong," which are anesthesia conduction needles. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications for use stated.

Therefore, I cannot provide the requested information.

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).