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FDA 510(k)

UROSURGE UROSTENT

K-Number: K973504 · 1998-01-30

ApplicantPrinceton Regulatory Assoc.
Decision Date1998-01-30
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROSURGE UROSTENT is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Regulatory Assoc.. It received FDA 510(k) clearance on 1998-01-30 under 510(k) number K973504. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROSURGE UROSTENT?

UROSURGE UROSTENT is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Princeton Regulatory Assoc.. The 510(k) number is K973504.

When did UROSURGE UROSTENT receive FDA 510(k) clearance?

UROSURGE UROSTENT received FDA 510(k) clearance on 1998-01-30, under 510(k) number K973504.

Who is the listed applicant for UROSURGE UROSTENT?

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

What is the FDA product code for UROSURGE UROSTENT?

The FDA product code for UROSURGE UROSTENT is FAD.

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Other records listing Princeton Regulatory Assoc. 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.

K965136UROSURGE UROTHERM FLUID WARMING SYSTEMK972158GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESK962770UROSURGE ACUTRAINER

Related Devices (Code: FAD)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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