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FDA 510(k)

Codman EDS3 CSF External Drainage System

K-Number: K162437 · 2016-10-28

ApplicantCodman & Shurtleff, Inc.
Decision Date2016-10-28
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Codman EDS3 CSF External Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K162437. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Codman EDS3 CSF External Drainage System?

Codman EDS3 CSF External Drainage System is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K162437.

When did Codman EDS3 CSF External Drainage System receive FDA 510(k) clearance?

Codman EDS3 CSF External Drainage System received FDA 510(k) clearance on 2016-10-28, under 510(k) number K162437.

Who is the listed applicant for Codman EDS3 CSF External Drainage System?

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

What is the FDA product code for Codman EDS3 CSF External Drainage System?

The FDA product code for Codman EDS3 CSF External Drainage System is JXG.

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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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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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