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FDA 510(k)

CIRCLE NEPHROSTOMY CATHETER SET

K-Number: K961933 · 1996-07-18

ApplicantCook Urological, Inc.
Decision Date1996-07-18
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

CIRCLE NEPHROSTOMY 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 1996-07-18 under 510(k) number K961933. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCLE NEPHROSTOMY CATHETER SET?

CIRCLE NEPHROSTOMY CATHETER SET is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Cook Urological, Inc.. The 510(k) number is K961933.

When did CIRCLE NEPHROSTOMY CATHETER SET receive FDA 510(k) clearance?

CIRCLE NEPHROSTOMY CATHETER SET received FDA 510(k) clearance on 1996-07-18, under 510(k) number K961933.

Who is the listed applicant for CIRCLE NEPHROSTOMY 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 CIRCLE NEPHROSTOMY CATHETER SET?

The FDA product code for CIRCLE NEPHROSTOMY CATHETER SET is LJE.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: LJE)

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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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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