FDA 510(k)

OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE

K-Number: K961697 · 1996-08-30

Decision Date1996-08-30

Product CodeEZL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Intl., Inc.. It received FDA 510(k) clearance on 1996-08-30 under 510(k) number K961697. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE?

OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Medical Device Intl., Inc.. The 510(k) number is K961697.

When did OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE receive FDA 510(k) clearance?

OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE received FDA 510(k) clearance on 1996-08-30, under 510(k) number K961697.

Who is the listed applicant for OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE?

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

What is the FDA product code for OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE?

The FDA product code for OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE is EZL.

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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.