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FDA 510(k)

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL

K-Number: K943801 · 1995-08-15

ApplicantRocket of London, Ltd.
Decision Date1995-08-15
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Rocket of London, Ltd.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K943801. 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 URIGLOW TRANSILLUMINATING URETERIC STENT MODEL?

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Rocket of London, Ltd.. The 510(k) number is K943801.

When did URIGLOW TRANSILLUMINATING URETERIC STENT MODEL receive FDA 510(k) clearance?

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL received FDA 510(k) clearance on 1995-08-15, under 510(k) number K943801.

Who is the listed applicant for URIGLOW TRANSILLUMINATING URETERIC STENT MODEL?

The FDA 510(k) record lists Rocket of London, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIGLOW TRANSILLUMINATING URETERIC STENT MODEL?

The FDA product code for URIGLOW TRANSILLUMINATING URETERIC STENT MODEL is FCS.

Related Clinical Trials

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Other records listing Rocket of London, Ltd. 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.

K935665INTRAUTERINE SOUNDK932385SUTURE REMOVING FORCEPS

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.K982542STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker EndoscopyK945088GABRIEL 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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