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FDA 510(k)

SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS

K-Number: K081613 · 2008-09-17

ApplicantAmerican Medical Systems, Inc.
Decision Date2008-09-17
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K081613. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS?

SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K081613.

When did SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS receive FDA 510(k) clearance?

SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS received FDA 510(k) clearance on 2008-09-17, under 510(k) number K081613.

Who is the listed applicant for SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS?

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

What is the FDA product code for SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS?

The FDA product code for SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS is OTN.

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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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