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FDA 510(k)

PERCUTANEOUS DRAINAGE LOOP CATHETER SET

K-Number: K931195 · 1993-12-22

ApplicantCook Urological, Inc.
Decision Date1993-12-22
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS DRAINAGE LOOP CATHETER SET 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 1993-12-22 under 510(k) number K931195. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS DRAINAGE LOOP CATHETER SET?

PERCUTANEOUS DRAINAGE LOOP CATHETER SET is a medical device that received FDA 510(k) clearance on 1993-12-22. The listed applicant is Cook Urological, Inc.. The 510(k) number is K931195.

When did PERCUTANEOUS DRAINAGE LOOP CATHETER SET receive FDA 510(k) clearance?

PERCUTANEOUS DRAINAGE LOOP CATHETER SET received FDA 510(k) clearance on 1993-12-22, under 510(k) number K931195.

Who is the listed applicant for PERCUTANEOUS DRAINAGE LOOP CATHETER SET?

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 PERCUTANEOUS DRAINAGE LOOP CATHETER SET?

The FDA product code for PERCUTANEOUS DRAINAGE LOOP CATHETER SET is KOD.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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