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FDA 510(k)

REMEEX SYSTEM FOR URINARY INCONTINENCE

K-Number: K033310 · 2004-01-15

ApplicantSpecialities Remeex International, S.L.
Decision Date2004-01-15
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REMEEX SYSTEM FOR URINARY INCONTINENCE is the device name listed in this FDA 510(k) record. The listed applicant is Specialities Remeex International, S.L.. It received FDA 510(k) clearance on 2004-01-15 under 510(k) number K033310. 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 REMEEX SYSTEM FOR URINARY INCONTINENCE?

REMEEX SYSTEM FOR URINARY INCONTINENCE is a medical device that received FDA 510(k) clearance on 2004-01-15. The listed applicant is Specialities Remeex International, S.L.. The 510(k) number is K033310.

When did REMEEX SYSTEM FOR URINARY INCONTINENCE receive FDA 510(k) clearance?

REMEEX SYSTEM FOR URINARY INCONTINENCE received FDA 510(k) clearance on 2004-01-15, under 510(k) number K033310.

Who is the listed applicant for REMEEX SYSTEM FOR URINARY INCONTINENCE?

The FDA 510(k) record lists Specialities Remeex International, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMEEX SYSTEM FOR URINARY INCONTINENCE?

The FDA product code for REMEEX SYSTEM FOR URINARY INCONTINENCE is OTN.

Related Clinical Trials

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Other records listing Specialities Remeex International, S.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.

K063136NEEDLELESS SLINGK062341MALE REMEEX SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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