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FDA 510(k)

PHTIP DISPOSABLE ISFET CATHETER

K-Number: K102801 · 2010-10-26

ApplicantE-Cath Co., Ltd.
Decision Date2010-10-26
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHTIP DISPOSABLE ISFET CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is E-Cath Co., Ltd.. It received FDA 510(k) clearance on 2010-10-26 under 510(k) number K102801. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHTIP DISPOSABLE ISFET CATHETER?

PHTIP DISPOSABLE ISFET CATHETER is a medical device that received FDA 510(k) clearance on 2010-10-26. The listed applicant is E-Cath Co., Ltd.. The 510(k) number is K102801.

When did PHTIP DISPOSABLE ISFET CATHETER receive FDA 510(k) clearance?

PHTIP DISPOSABLE ISFET CATHETER received FDA 510(k) clearance on 2010-10-26, under 510(k) number K102801.

Who is the listed applicant for PHTIP DISPOSABLE ISFET CATHETER?

The FDA 510(k) record lists E-Cath Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHTIP DISPOSABLE ISFET CATHETER?

The FDA product code for PHTIP DISPOSABLE ISFET CATHETER is FFX.

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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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