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FDA 510(k)

AQ HYDROPHILIC UROLOGICAL CATHETERS

K-Number: K962004 · 1996-06-11

ApplicantCook Urological, Inc.
Decision Date1996-06-11
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQ HYDROPHILIC UROLOGICAL CATHETERS 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 1996-06-11 under 510(k) number K962004. 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 AQ HYDROPHILIC UROLOGICAL CATHETERS?

AQ HYDROPHILIC UROLOGICAL CATHETERS is a medical device that received FDA 510(k) clearance on 1996-06-11. The listed applicant is Cook Urological, Inc.. The 510(k) number is K962004.

When did AQ HYDROPHILIC UROLOGICAL CATHETERS receive FDA 510(k) clearance?

AQ HYDROPHILIC UROLOGICAL CATHETERS received FDA 510(k) clearance on 1996-06-11, under 510(k) number K962004.

Who is the listed applicant for AQ HYDROPHILIC UROLOGICAL CATHETERS?

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 AQ HYDROPHILIC UROLOGICAL CATHETERS?

The FDA product code for AQ HYDROPHILIC UROLOGICAL CATHETERS is EYB.

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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: EYB)

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.

K192183RocaTub Ureteral CatheterPromepal SamK191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook IncorporatedK182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook IncorporatedK182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated

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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