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Found 3 results
510(k) Data Aggregation
K Number
K040565Device Name
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
Manufacturer
PHYSICIAN INDUSTRIES, INC.
Date Cleared
2004-07-22
(141 days)
Product Code
GXD, GXI
Regulation Number
882.4400Why did this record match?
Applicant Name (Manufacturer) :
PHYSICIAN INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Physician Industries' Radiofrequency Ablation Needle is a single use RF (radiofrequency) needle with injection capabilities. It can be used for either 1) (Fadiofrequency) in the lesioning, or 2) percutaneous nerve blocks with a local anesthetic solution. The nerve is localized by using electrical stimulation through the needle. The nerve may then be blocked either by the generating an RF lesion, or by the injecting of a local anesthetic. It is to be used only under the direction of a licensed clinician.
Device Description
The Physician Industries Inc. needle shares major similarities with the predicate device(s), inasmuch as the configuration, material, use, labeling and safety issues remain basically unchanged. It consists of a plastic hub, insert molded over a PTFE-coated stainless steel cannula.
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K Number
K033739Device Name
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
Manufacturer
PHYSICIAN INDUSTRIES, INC.
Date Cleared
2004-07-12
(227 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
PHYSICIAN INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in diagnosis of herniated or otherwise diseased intervertebral disks in the human spine. This device has not been evaluated for use in vertebroplasty.
Device Description
The Physician Industries' ACCUMETER. Polycarbonate barrel, plunger, and body, containing display software and electronics; Rubber plunger tip. Sterile (100% EtO) and non-pyrogenic (LAL).
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K Number
K960248Device Name
GENERAL PROCEDURE KIT
Manufacturer
PHYSICIAN INDUSTRIES, INC.
Date Cleared
1996-04-12
(87 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
PHYSICIAN INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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