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FDA 510(k)

T-SLING

K-Number: K050516 · 2006-02-03

ApplicantHerniamesh S.R.L.
Decision Date2006-02-03
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

T-SLING is the device name listed in this FDA 510(k) record. The listed applicant is Herniamesh S.R.L.. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K050516. 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 T-SLING?

T-SLING is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Herniamesh S.R.L.. The 510(k) number is K050516.

When did T-SLING receive FDA 510(k) clearance?

T-SLING received FDA 510(k) clearance on 2006-02-03, under 510(k) number K050516.

Who is the listed applicant for T-SLING?

The FDA 510(k) record lists Herniamesh S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-SLING?

The FDA product code for T-SLING is OTN.

Related Clinical Trials

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.

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Other records listing Herniamesh S.R.L. as applicant

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.

K081327RELIMESH

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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