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FDA 510(k)

ILLUMINATED URETERAL CATHETER

K-Number: K923436 · 1993-03-05

ApplicantCook Urological, Inc.
Decision Date1993-03-05
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ILLUMINATED URETERAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1993-03-05 under 510(k) number K923436. 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 ILLUMINATED URETERAL CATHETER?

ILLUMINATED URETERAL CATHETER is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is Cook Urological, Inc.. The 510(k) number is K923436.

When did ILLUMINATED URETERAL CATHETER receive FDA 510(k) clearance?

ILLUMINATED URETERAL CATHETER received FDA 510(k) clearance on 1993-03-05, under 510(k) number K923436.

Who is the listed applicant for ILLUMINATED URETERAL CATHETER?

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

What is the FDA product code for ILLUMINATED URETERAL CATHETER?

The FDA product code for ILLUMINATED URETERAL CATHETER is FCS.

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Other records listing Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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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.K982542STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker EndoscopyK943801URIGLOW TRANSILLUMINATING URETERIC STENT MODELRocket of London, Ltd.K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIGabriel Medical, Inc.K941506URETERAL ILLUMINATORApple Medical Corp.K940019GABRIEL URETERAL ILLUMINATOR SYSTEMGabriel Medical, 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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