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FDA 510(k)

SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS

K-Number: K041948 · 2004-08-11

ApplicantAmerican Medical Systems, Inc.
Decision Date2004-08-11
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPARC, MONARC, BIOARC SP AND BIOARC TO SLING 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 2004-08-11 under 510(k) number K041948. 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, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS?

SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-08-11. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K041948.

When did SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS receive FDA 510(k) clearance?

SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS received FDA 510(k) clearance on 2004-08-11, under 510(k) number K041948.

Who is the listed applicant for SPARC, MONARC, BIOARC SP AND BIOARC TO SLING 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, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS?

The FDA product code for SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS is OTN.

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Related Devices (Code: 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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