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FDA 510(k)

SUPRIS RETROPUBIC SLING SYSTEM

K-Number: K111233 · 2011-06-24

ApplicantColoplast A/S
Decision Date2011-06-24
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPRIS RETROPUBIC SLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K111233. 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 SUPRIS RETROPUBIC SLING SYSTEM?

SUPRIS RETROPUBIC SLING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Coloplast A/S. The 510(k) number is K111233.

When did SUPRIS RETROPUBIC SLING SYSTEM receive FDA 510(k) clearance?

SUPRIS RETROPUBIC SLING SYSTEM received FDA 510(k) clearance on 2011-06-24, under 510(k) number K111233.

Who is the listed applicant for SUPRIS RETROPUBIC SLING SYSTEM?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPRIS RETROPUBIC SLING SYSTEM?

The FDA product code for SUPRIS RETROPUBIC SLING SYSTEM is OTN.

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Other records listing Coloplast A/S 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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