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FDA 510(k)

URETHAL CATHETER

K-Number: K874309 · 1987-12-07

ApplicantMedovations, Inc.
Decision Date1987-12-07
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medovations, Inc.. It received FDA 510(k) clearance on 1987-12-07 under 510(k) number K874309. 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 URETHAL CATHETER?

URETHAL CATHETER is a medical device that received FDA 510(k) clearance on 1987-12-07. The listed applicant is Medovations, Inc.. The 510(k) number is K874309.

When did URETHAL CATHETER receive FDA 510(k) clearance?

URETHAL CATHETER received FDA 510(k) clearance on 1987-12-07, under 510(k) number K874309.

Who is the listed applicant for URETHAL CATHETER?

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

What is the FDA product code for URETHAL CATHETER?

The FDA product code for URETHAL CATHETER is KNX.

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Other records listing Medovations, 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.

K002363MEDOVATIONS ESOPHAGEAL DILATORK972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)K924646OVER THE GUIDEWIRE DILATATION SYSTEMK913678TROCAR CATHETERK905478YANKAUER SUCTION DEVICEK864963STOMACH EVACULATOR - EWALD STYLE

View all 30 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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