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FDA 510(k)

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION

K-Number: K903994 · 1990-10-19

ApplicantApplied Urology, Inc.
Decision Date1990-10-19
Product CodeFGF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION is the device name listed in this FDA 510(k) record. The listed applicant is Applied Urology, Inc.. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K903994. The device is classified under product code FGF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION?

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Applied Urology, Inc.. The 510(k) number is K903994.

When did URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION receive FDA 510(k) clearance?

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION received FDA 510(k) clearance on 1990-10-19, under 510(k) number K903994.

Who is the listed applicant for URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION?

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

What is the FDA product code for URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION?

The FDA product code for URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION is FGF.

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Other records listing Applied Urology, 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.

K921838ACUCISE URETERAL CUTTING CATHETERK925282UROLOGICAL CATHETER AND ACCESSORIESK920695URETERAL STENTK915219URETHRAL ELECTRODE SHEATHK912093DISPOSABLE ASPIRATION IRRIGATION SYSTEMK920030SURESEAL ENDOSCOPIC VALVE

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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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