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FDA 510(k)

ZIP CONDOM CATHETER

K-Number: K964219 · 1997-08-11

ApplicantGoulter Medical, Inc.
Decision Date1997-08-11
Product CodeEYZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ZIP CONDOM CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Goulter Medical, Inc.. It received FDA 510(k) clearance on 1997-08-11 under 510(k) number K964219. The device is classified under product code EYZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIP CONDOM CATHETER?

ZIP CONDOM CATHETER is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Goulter Medical, Inc.. The 510(k) number is K964219.

When did ZIP CONDOM CATHETER receive FDA 510(k) clearance?

ZIP CONDOM CATHETER received FDA 510(k) clearance on 1997-08-11, under 510(k) number K964219.

Who is the listed applicant for ZIP CONDOM CATHETER?

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

What is the FDA product code for ZIP CONDOM CATHETER?

The FDA product code for ZIP CONDOM CATHETER is EYZ.

Related Clinical Trials

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.

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Related Devices (Code: EYZ)

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.

K961906UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.K952780URINARY GEL DRAINAGE SYSTEMP.A.M., Inc.K951597URINARY DRAINAGE BAGKey Medical Services, Inc.K942753ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERResearched, Novel Medical Devices (Rn/Md)K933126COMFORTCARE SYSTEMPatsy J. Trisler, J.D.K930556NIGHT URINARY DRAINAGE BEDSIDE BAGEzmt Valve Co., Inc.

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.

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