FDA 510(k)

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX

K-Number: K021856 · 2002-10-17

Decision Date2002-10-17

Product CodeEYB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX is the device name listed in this FDA 510(k) record. The listed applicant is Porges S.A.. It received FDA 510(k) clearance on 2002-10-17 under 510(k) number K021856. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX?

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX is a medical device that received FDA 510(k) clearance on 2002-10-17. The listed applicant is Porges S.A.. The 510(k) number is K021856.

When did PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX receive FDA 510(k) clearance?

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX received FDA 510(k) clearance on 2002-10-17, under 510(k) number K021856.

Who is the listed applicant for PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX?

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

What is the FDA product code for PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX?

The FDA product code for PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX is EYB.

Related Clinical Trials

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Other records listing Porges S.A. as applicant

K013921PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

Related Devices (Code: EYB)

K192183RocaTub Ureteral CatheterPromepal Sam K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook Incorporated K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated K182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated

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.