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FDA 510(k)

MORHEL CLOSED URINARY DRAINAGE SET

K-Number: K831622 · 1983-08-11

ApplicantMorhel Mexicana
Decision Date1983-08-11
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MORHEL CLOSED URINARY DRAINAGE SET is the device name listed in this FDA 510(k) record. The listed applicant is Morhel Mexicana. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831622. 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 MORHEL CLOSED URINARY DRAINAGE SET?

MORHEL CLOSED URINARY DRAINAGE SET is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Morhel Mexicana. The 510(k) number is K831622.

When did MORHEL CLOSED URINARY DRAINAGE SET receive FDA 510(k) clearance?

MORHEL CLOSED URINARY DRAINAGE SET received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831622.

Who is the listed applicant for MORHEL CLOSED URINARY DRAINAGE SET?

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

What is the FDA product code for MORHEL CLOSED URINARY DRAINAGE SET?

The FDA product code for MORHEL CLOSED URINARY DRAINAGE SET is KNX.

Related Clinical Trials

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.

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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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