FDA 510(k)

CODMAN INTRACRANIAL BOLT

K-Number: K974088 · 1998-01-09

ApplicantJohnson & Johnson Professionals, Inc.

Decision Date1998-01-09

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN INTRACRANIAL BOLT is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K974088. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN INTRACRANIAL BOLT?

CODMAN INTRACRANIAL BOLT is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K974088.

When did CODMAN INTRACRANIAL BOLT receive FDA 510(k) clearance?

CODMAN INTRACRANIAL BOLT received FDA 510(k) clearance on 1998-01-09, under 510(k) number K974088.

Who is the listed applicant for CODMAN INTRACRANIAL BOLT?

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

What is the FDA product code for CODMAN INTRACRANIAL BOLT?

The FDA product code for CODMAN INTRACRANIAL BOLT is GWM.

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Official Source

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