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FDA 510(k)

CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION

K-Number: K924755 · 1993-06-22

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1993-06-22
Product CodeEXI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K924755. The device is classified under product code EXI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION?

CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K924755.

When did CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION receive FDA 510(k) clearance?

CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION received FDA 510(k) clearance on 1993-06-22, under 510(k) number K924755.

Who is the listed applicant for CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION?

The FDA product code for CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION is EXI.

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

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Related Devices (Code: EXI)

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.

K971499FEMALE EXTERNAL URINARY COLLECTION POUCHMediquest, Inc.K970443HOLLISTER RETRACTED PENIS POUCHHollister, Inc.K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, Inc.K931277HOLLISTER PREMIUM URINE COLLECTORHollister, Inc.K915246CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)Coloplast A/SK915616URIHESIVE STRIPConvatec, A Division of E.R. Squibb & Sons

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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