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FDA 510(k)

PEDIATRIC URINE COLLECTOR

K-Number: K823411 · 1982-12-28

ApplicantSage Products, Inc.
Decision Date1982-12-28
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC URINE COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sage Products, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823411. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC URINE COLLECTOR?

PEDIATRIC URINE COLLECTOR is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Sage Products, Inc.. The 510(k) number is K823411.

When did PEDIATRIC URINE COLLECTOR receive FDA 510(k) clearance?

PEDIATRIC URINE COLLECTOR received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823411.

Who is the listed applicant for PEDIATRIC URINE COLLECTOR?

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

What is the FDA product code for PEDIATRIC URINE COLLECTOR?

The FDA product code for PEDIATRIC URINE COLLECTOR is KNX.

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Other records listing Sage Products, 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.

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK9739112 GALLON ALTERNATE CARE SHARPS CONTAINERK972279SHARPS SHUTTLEK970135NITRILE GLOVESK972302POCKET COUNT OR SAFETCOUNT

View all 31 devices →

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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