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FDA 510(k)

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

K-Number: K172022 · 2017-10-03

ApplicantCodman & Shurtleff, Inc.
Decision Date2017-10-03
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) 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 2017-10-03 under 510(k) number K172022. 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 Hydrocephalus Valves, Catheters & Accessories (Bundled)?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is a medical device that received FDA 510(k) clearance on 2017-10-03. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K172022.

When did CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) receive FDA 510(k) clearance?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) received FDA 510(k) clearance on 2017-10-03, under 510(k) number K172022.

Who is the listed applicant for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

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 Hydrocephalus Valves, Catheters & Accessories (Bundled)?

The FDA product code for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is JXG.

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Related Devices (Code: JXG)

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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