FDA 510(k)

SAPHYRE BIPOLAR ABLATION PROBES

K-Number: K031371 · 2003-05-23

Decision Date2003-05-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SAPHYRE BIPOLAR ABLATION PROBES 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 2003-05-23 under 510(k) number K031371. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPHYRE BIPOLAR ABLATION PROBES?

SAPHYRE BIPOLAR ABLATION PROBES is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K031371.

When did SAPHYRE BIPOLAR ABLATION PROBES receive FDA 510(k) clearance?

SAPHYRE BIPOLAR ABLATION PROBES received FDA 510(k) clearance on 2003-05-23, under 510(k) number K031371.

Who is the listed applicant for SAPHYRE BIPOLAR ABLATION PROBES?

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 SAPHYRE BIPOLAR ABLATION PROBES?

The FDA product code for SAPHYRE BIPOLAR ABLATION PROBES is GEI.

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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.