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FDA 510(k)

FEMALE URINE SAMPLING DEVICE

K-Number: K922346 · 1992-08-14

ApplicantMentor Corp.
Decision Date1992-08-14
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMALE URINE SAMPLING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1992-08-14 under 510(k) number K922346. The device is classified under product code FCN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMALE URINE SAMPLING DEVICE?

FEMALE URINE SAMPLING DEVICE is a medical device that received FDA 510(k) clearance on 1992-08-14. The listed applicant is Mentor Corp.. The 510(k) number is K922346.

When did FEMALE URINE SAMPLING DEVICE receive FDA 510(k) clearance?

FEMALE URINE SAMPLING DEVICE received FDA 510(k) clearance on 1992-08-14, under 510(k) number K922346.

Who is the listed applicant for FEMALE URINE SAMPLING DEVICE?

The FDA 510(k) record lists Mentor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMALE URINE SAMPLING DEVICE?

The FDA product code for FEMALE URINE SAMPLING DEVICE is FCN.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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Related Devices (Code: FCN)

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.

K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.K945258CATCO URINARY COLLECTION KITCatco Medical, Inc.K915166MICROCYCLERMedical Inventors Corp., Inc.K890096BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.K883610LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.

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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