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FDA 510(k)

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

K-Number: K013276 · 2002-02-15

ApplicantSewoon Medical Co., Ltd.
Decision Date2002-02-15
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) is the device name listed in this FDA 510(k) record. The listed applicant is Sewoon Medical Co., Ltd.. It received FDA 510(k) clearance on 2002-02-15 under 510(k) number K013276. 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 ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)?

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) is a medical device that received FDA 510(k) clearance on 2002-02-15. The listed applicant is Sewoon Medical Co., Ltd.. The 510(k) number is K013276.

When did ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) receive FDA 510(k) clearance?

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) received FDA 510(k) clearance on 2002-02-15, under 510(k) number K013276.

Who is the listed applicant for ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)?

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

What is the FDA product code for ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)?

The FDA product code for ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) is EZL.

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Related Devices (Code: EZL)

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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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