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FDA 510(k)

SINGLE USE BALLOON DILATOR MAXPASSTM

K-Number: K050502 · 2005-07-08

ApplicantOlympus Winter & Ibe GmbH
Decision Date2005-07-08
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE USE BALLOON DILATOR MAXPASSTM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2005-07-08 under 510(k) number K050502. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE BALLOON DILATOR MAXPASSTM?

SINGLE USE BALLOON DILATOR MAXPASSTM is a medical device that received FDA 510(k) clearance on 2005-07-08. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K050502.

When did SINGLE USE BALLOON DILATOR MAXPASSTM receive FDA 510(k) clearance?

SINGLE USE BALLOON DILATOR MAXPASSTM received FDA 510(k) clearance on 2005-07-08, under 510(k) number K050502.

Who is the listed applicant for SINGLE USE BALLOON DILATOR MAXPASSTM?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE USE BALLOON DILATOR MAXPASSTM?

The FDA product code for SINGLE USE BALLOON DILATOR MAXPASSTM is FGE.

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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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