FDA 510(k)

SMITH & NEPHEW IUR MORCELLATION SYSTEM

K-Number: K031787 · 2003-12-02

Decision Date2003-12-02

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW IUR MORCELLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2003-12-02 under 510(k) number K031787. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW IUR MORCELLATION SYSTEM?

SMITH & NEPHEW IUR MORCELLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-02. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K031787.

When did SMITH & NEPHEW IUR MORCELLATION SYSTEM receive FDA 510(k) clearance?

SMITH & NEPHEW IUR MORCELLATION SYSTEM received FDA 510(k) clearance on 2003-12-02, under 510(k) number K031787.

Who is the listed applicant for SMITH & NEPHEW IUR MORCELLATION SYSTEM?

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

What is the FDA product code for SMITH & NEPHEW IUR MORCELLATION SYSTEM?

The FDA product code for SMITH & NEPHEW IUR MORCELLATION SYSTEM is HIH.

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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.