FDA 510(k)

NORTEC URETERAL STENT

K-Number: K910691 · 1991-08-15

ApplicantNorth American Sterilization & Packaging Co.

Decision Date1991-08-15

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NORTEC URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is North American Sterilization & Packaging Co.. It received FDA 510(k) clearance on 1991-08-15 under 510(k) number K910691. 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 NORTEC URETERAL STENT?

NORTEC URETERAL STENT is a medical device that received FDA 510(k) clearance on 1991-08-15. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K910691.

When did NORTEC URETERAL STENT receive FDA 510(k) clearance?

NORTEC URETERAL STENT received FDA 510(k) clearance on 1991-08-15, under 510(k) number K910691.

Who is the listed applicant for NORTEC URETERAL STENT?

The FDA 510(k) record lists North American Sterilization & Packaging Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTEC URETERAL STENT?

The FDA product code for NORTEC URETERAL STENT is FAD.

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Other records listing North American Sterilization & Packaging Co. as applicant

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Related Devices (Code: FAD)

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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.