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FDA 510(k)

STERILE URETHRAL CATHETERIZATION SET

K-Number: K821978 · 1982-08-25

ApplicantMedical Devices, Inc.
Decision Date1982-08-25
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE URETHRAL CATHETERIZATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1982-08-25 under 510(k) number K821978. 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 STERILE URETHRAL CATHETERIZATION SET?

STERILE URETHRAL CATHETERIZATION SET is a medical device that received FDA 510(k) clearance on 1982-08-25. The listed applicant is Medical Devices, Inc.. The 510(k) number is K821978.

When did STERILE URETHRAL CATHETERIZATION SET receive FDA 510(k) clearance?

STERILE URETHRAL CATHETERIZATION SET received FDA 510(k) clearance on 1982-08-25, under 510(k) number K821978.

Who is the listed applicant for STERILE URETHRAL CATHETERIZATION SET?

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

What is the FDA product code for STERILE URETHRAL CATHETERIZATION SET?

The FDA product code for STERILE URETHRAL CATHETERIZATION SET is KNX.

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Other records listing Medical Devices, 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.

K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATE

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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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