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FDA 510(k)

DISTENTION BALLOON

K-Number: K953377 · 1995-10-23

ApplicantOrigin Medsystems, Inc.
Decision Date1995-10-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISTENTION BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K953377. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISTENTION BALLOON?

DISTENTION BALLOON is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K953377.

When did DISTENTION BALLOON receive FDA 510(k) clearance?

DISTENTION BALLOON received FDA 510(k) clearance on 1995-10-23, under 510(k) number K953377.

Who is the listed applicant for DISTENTION BALLOON?

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

What is the FDA product code for DISTENTION BALLOON?

The FDA product code for DISTENTION BALLOON is GCJ.

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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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