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FDA 510(k)

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012

K-Number: K101440 · 2010-06-18

ApplicantGeneric Medical Devices, Inc.
Decision Date2010-06-18
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 is the device name listed in this FDA 510(k) record. The listed applicant is Generic Medical Devices, Inc.. It received FDA 510(k) clearance on 2010-06-18 under 510(k) number K101440. 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, MODEL 1012?

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 is a medical device that received FDA 510(k) clearance on 2010-06-18. The listed applicant is Generic Medical Devices, Inc.. The 510(k) number is K101440.

When did GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 receive FDA 510(k) clearance?

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 received FDA 510(k) clearance on 2010-06-18, under 510(k) number K101440.

Who is the listed applicant for GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012?

The FDA 510(k) record lists Generic Medical Devices, 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, MODEL 1012?

The FDA product code for GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 is OTN.

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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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