FDA 510(k)

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

K-Number: K061009 · 2006-05-02

Decision Date2006-05-02

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS is the device name listed in this FDA 510(k) record. The listed applicant is Onset Medical Corporation. It received FDA 510(k) clearance on 2006-05-02 under 510(k) number K061009. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS?

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS is a medical device that received FDA 510(k) clearance on 2006-05-02. The listed applicant is Onset Medical Corporation. The 510(k) number is K061009.

When did PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS receive FDA 510(k) clearance?

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS received FDA 510(k) clearance on 2006-05-02, under 510(k) number K061009.

Who is the listed applicant for PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS?

The FDA 510(k) record lists Onset Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS?

The FDA product code for PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS is EZN.

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Other records listing Onset Medical Corporation as applicant

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Related Devices (Code: EZN)

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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.