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FDA 510(k)

URETEX SUP PUBOURETHRAL SLING

K-Number: K012949 · 2001-10-04

ApplicantSofradim Production
Decision Date2001-10-04
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

URETEX SUP PUBOURETHRAL SLING is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K012949. 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 URETEX SUP PUBOURETHRAL SLING?

URETEX SUP PUBOURETHRAL SLING is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Sofradim Production. The 510(k) number is K012949.

When did URETEX SUP PUBOURETHRAL SLING receive FDA 510(k) clearance?

URETEX SUP PUBOURETHRAL SLING received FDA 510(k) clearance on 2001-10-04, under 510(k) number K012949.

Who is the listed applicant for URETEX SUP PUBOURETHRAL SLING?

The FDA 510(k) record lists Sofradim Production as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URETEX SUP PUBOURETHRAL SLING?

The FDA product code for URETEX SUP PUBOURETHRAL SLING is OTN.

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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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