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FDA 510(k)

XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE

K-Number: K010666 · 2001-05-07

ApplicantMedtronic Xomed, Inc.
Decision Date2001-05-07
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2001-05-07 under 510(k) number K010666. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE?

XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE is a medical device that received FDA 510(k) clearance on 2001-05-07. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K010666.

When did XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE receive FDA 510(k) clearance?

XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE received FDA 510(k) clearance on 2001-05-07, under 510(k) number K010666.

Who is the listed applicant for XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE?

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

What is the FDA product code for XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE?

The FDA product code for XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE is QPB.

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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.

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