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FDA 510(k)

STRYKER URETERAL ILLUMINATOR SYSTEM III

K-Number: K982542 · 1998-09-22

ApplicantStryker Endoscopy
Decision Date1998-09-22
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STRYKER URETERAL ILLUMINATOR SYSTEM III is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982542. The device is classified under product code FCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER URETERAL ILLUMINATOR SYSTEM III?

STRYKER URETERAL ILLUMINATOR SYSTEM III is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Stryker Endoscopy. The 510(k) number is K982542.

When did STRYKER URETERAL ILLUMINATOR SYSTEM III receive FDA 510(k) clearance?

STRYKER URETERAL ILLUMINATOR SYSTEM III received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982542.

Who is the listed applicant for STRYKER URETERAL ILLUMINATOR SYSTEM III?

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

What is the FDA product code for STRYKER URETERAL ILLUMINATOR SYSTEM III?

The FDA product code for STRYKER URETERAL ILLUMINATOR SYSTEM III is FCS.

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Related Devices (Code: FCS)

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.

K061548STRYKER URETERAL ILLUMINATION SYSTEM IVStryker Corp.K943801URIGLOW TRANSILLUMINATING URETERIC STENT MODELRocket of London, Ltd.K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIGabriel Medical, Inc.K941506URETERAL ILLUMINATORApple Medical Corp.K940019GABRIEL URETERAL ILLUMINATOR SYSTEMGabriel Medical, Inc.K923436ILLUMINATED URETERAL CATHETERCook Urological, 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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