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FDA 510(k)

BIOARC SP SLING KIT

K-Number: K030123 · 2003-02-06

ApplicantAmerican Medical Systems, Inc.
Decision Date2003-02-06
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOARC SP SLING KIT 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 2003-02-06 under 510(k) number K030123. 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 BIOARC SP SLING KIT?

BIOARC SP SLING KIT is a medical device that received FDA 510(k) clearance on 2003-02-06. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K030123.

When did BIOARC SP SLING KIT receive FDA 510(k) clearance?

BIOARC SP SLING KIT received FDA 510(k) clearance on 2003-02-06, under 510(k) number K030123.

Who is the listed applicant for BIOARC SP SLING KIT?

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 BIOARC SP SLING KIT?

The FDA product code for BIOARC SP SLING KIT is OTN.

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Other records listing American Medical Systems, Inc. as applicant

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Related Devices (Code: OTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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