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FDA 510(k)

LIFTING DISTENTION BALLOON SYSTEM

K-Number: K942678 · 1994-07-08

ApplicantOrigin Medsystems, Inc.
Decision Date1994-07-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIFTING DISTENTION BALLOON SYSTEM 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 1994-07-08 under 510(k) number K942678. 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 LIFTING DISTENTION BALLOON SYSTEM?

LIFTING DISTENTION BALLOON SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-08. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K942678.

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

LIFTING DISTENTION BALLOON SYSTEM received FDA 510(k) clearance on 1994-07-08, under 510(k) number K942678.

Who is the listed applicant for LIFTING DISTENTION BALLOON SYSTEM?

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 LIFTING DISTENTION BALLOON SYSTEM?

The FDA product code for LIFTING DISTENTION BALLOON SYSTEM 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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