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FDA 510(k)

GMD UNIVERSAL URINARY INCONTINENCE SLING

K-Number: K111219 · 2011-06-30

ApplicantGeneric Medical Device, Inc.
Decision Date2011-06-30
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GMD UNIVERSAL URINARY INCONTINENCE SLING is the device name listed in this FDA 510(k) record. The listed applicant is Generic Medical Device, Inc.. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K111219. 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 GMD UNIVERSAL URINARY INCONTINENCE SLING?

GMD UNIVERSAL URINARY INCONTINENCE SLING is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Generic Medical Device, Inc.. The 510(k) number is K111219.

When did GMD UNIVERSAL URINARY INCONTINENCE SLING receive FDA 510(k) clearance?

GMD UNIVERSAL URINARY INCONTINENCE SLING received FDA 510(k) clearance on 2011-06-30, under 510(k) number K111219.

Who is the listed applicant for GMD UNIVERSAL URINARY INCONTINENCE SLING?

The FDA 510(k) record lists Generic Medical Device, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GMD UNIVERSAL URINARY INCONTINENCE SLING?

The FDA product code for GMD UNIVERSAL URINARY INCONTINENCE 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 Generic Medical Device, Inc. 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.

K083471GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020K070018UNIVERSAL SURGICAL MESH, MODEL 100K063429GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200

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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