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FDA 510(k)

CODMAN SOF'WIRE (TM) KIT

K-Number: K915581 · 1992-01-16

ApplicantCodman & Shurtleff, Inc.
Decision Date1992-01-16
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CODMAN SOF'WIRE (TM) KIT 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 1992-01-16 under 510(k) number K915581. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN SOF'WIRE (TM) KIT?

CODMAN SOF'WIRE (TM) KIT is a medical device that received FDA 510(k) clearance on 1992-01-16. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K915581.

When did CODMAN SOF'WIRE (TM) KIT receive FDA 510(k) clearance?

CODMAN SOF'WIRE (TM) KIT received FDA 510(k) clearance on 1992-01-16, under 510(k) number K915581.

Who is the listed applicant for CODMAN SOF'WIRE (TM) KIT?

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 SOF'WIRE (TM) KIT?

The FDA product code for CODMAN SOF'WIRE (TM) KIT is JDQ.

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Other records listing Codman & Shurtleff, Inc. as applicant

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Related Devices (Code: JDQ)

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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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