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FDA 510(k)

FOLHY CATHETER

K-Number: K771860 · 1977-10-18

ApplicantPolysil, Inc.
Decision Date1977-10-18
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOLHY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Polysil, Inc.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771860. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOLHY CATHETER?

FOLHY CATHETER is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Polysil, Inc.. The 510(k) number is K771860.

When did FOLHY CATHETER receive FDA 510(k) clearance?

FOLHY CATHETER received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771860.

Who is the listed applicant for FOLHY CATHETER?

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

What is the FDA product code for FOLHY CATHETER?

The FDA product code for FOLHY CATHETER is EZL.

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Related Devices (Code: EZL)

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

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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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