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FDA 510(k)

VANCE URETHAL DILATOR SET

K-Number: K810371 · 1981-03-20

ApplicantVance Products, Inc.
Decision Date1981-03-20
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VANCE URETHAL DILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Vance Products, Inc.. It received FDA 510(k) clearance on 1981-03-20 under 510(k) number K810371. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANCE URETHAL DILATOR SET?

VANCE URETHAL DILATOR SET is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Vance Products, Inc.. The 510(k) number is K810371.

When did VANCE URETHAL DILATOR SET receive FDA 510(k) clearance?

VANCE URETHAL DILATOR SET received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810371.

Who is the listed applicant for VANCE URETHAL DILATOR SET?

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

What is the FDA product code for VANCE URETHAL DILATOR SET?

The FDA product code for VANCE URETHAL DILATOR SET is KOE.

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Other records listing Vance 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.

K820313VPI-FAIR URETHRAL STENTK812995VANCE-JACOBELLIS MICROHEMATURIA CATHETERK813278VPI URETERAL DILATATION BALLON CATHETERK812785VANCE-AMBROSE RESECTOSCOPE FORCEPSK812057VANCE CYSTOSCOPICK811833VNACE FASCIAL DILATOR SET

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Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical Corp.

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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