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FDA 510(k)

UNIVERSAL INSTRU. SET FOR NEUROVASCULAR

K-Number: K831071 · 1983-06-08

ApplicantProthia USA, Inc.
Decision Date1983-06-08
Product CodeGZX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL INSTRU. SET FOR NEUROVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Prothia USA, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831071. The device is classified under product code GZX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL INSTRU. SET FOR NEUROVASCULAR?

UNIVERSAL INSTRU. SET FOR NEUROVASCULAR is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Prothia USA, Inc.. The 510(k) number is K831071.

When did UNIVERSAL INSTRU. SET FOR NEUROVASCULAR receive FDA 510(k) clearance?

UNIVERSAL INSTRU. SET FOR NEUROVASCULAR received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831071.

Who is the listed applicant for UNIVERSAL INSTRU. SET FOR NEUROVASCULAR?

The FDA 510(k) record lists Prothia USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL INSTRU. SET FOR NEUROVASCULAR?

The FDA product code for UNIVERSAL INSTRU. SET FOR NEUROVASCULAR is GZX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Prothia USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K830993AMPLIGREFFEK823581ELPHA 500K830058MYOGRAPH 2000K823583MYOTEST NERVE STIMULATOR

Related Devices (Code: GZX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932169MICROSURGICAL INSTRUMENTSAmerican Russian Medical Services, Inc.K926048CLARUS ENDOSCOPIC BALL PROBEClarus Medical Systems, Inc.K911932J105 JAMES SURGICAL SYSTEM I/A PACKO.R. Specialties, Inc.K890216MICROSURGICAL KERATOMEKinetic Medical ProductsK873933RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUMDowns Surgical , Ltd.K873934RANGE OF CROCODILE ACTION INSTRUMENTSDowns Surgical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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