FDA 510(k)

CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)

K-Number: K910938 · 1991-08-16

Decision Date1991-08-16

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) 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 1991-08-16 under 510(k) number K910938. 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 EXTERNAL DRAINAGE SYSTEM II (EDS II)?

CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K910938.

When did CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) receive FDA 510(k) clearance?

CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) received FDA 510(k) clearance on 1991-08-16, under 510(k) number K910938.

Who is the listed applicant for CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)?

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 EXTERNAL DRAINAGE SYSTEM II (EDS II)?

The FDA product code for CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) is JXG.

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Other records listing Codman & Shurtleff, Inc. as applicant

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Related Devices (Code: JXG)

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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.