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FDA 510(k)

RUSCH MMG/O'NEIL CATHETER

K-Number: K010420 · 2001-05-09

ApplicantRusch, Inc.
Decision Date2001-05-09
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RUSCH MMG/O'NEIL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 2001-05-09 under 510(k) number K010420. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH MMG/O'NEIL CATHETER?

RUSCH MMG/O'NEIL CATHETER is a medical device that received FDA 510(k) clearance on 2001-05-09. The listed applicant is Rusch, Inc.. The 510(k) number is K010420.

When did RUSCH MMG/O'NEIL CATHETER receive FDA 510(k) clearance?

RUSCH MMG/O'NEIL CATHETER received FDA 510(k) clearance on 2001-05-09, under 510(k) number K010420.

Who is the listed applicant for RUSCH MMG/O'NEIL CATHETER?

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

What is the FDA product code for RUSCH MMG/O'NEIL CATHETER?

The FDA product code for RUSCH MMG/O'NEIL CATHETER is FCM.

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Other records listing Rusch, Inc. as applicant

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Related Devices (Code: FCM)

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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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