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FDA 510(k)

DISTENTION INSTRUMENT, MODIFICATION

K-Number: K934134 · 1993-10-05

ApplicantOrigin Medsystems, Inc.
Decision Date1993-10-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISTENTION INSTRUMENT, MODIFICATION 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 1993-10-05 under 510(k) number K934134. 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 INSTRUMENT, MODIFICATION?

DISTENTION INSTRUMENT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-10-05. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K934134.

When did DISTENTION INSTRUMENT, MODIFICATION receive FDA 510(k) clearance?

DISTENTION INSTRUMENT, MODIFICATION received FDA 510(k) clearance on 1993-10-05, under 510(k) number K934134.

Who is the listed applicant for DISTENTION INSTRUMENT, MODIFICATION?

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 INSTRUMENT, MODIFICATION?

The FDA product code for DISTENTION INSTRUMENT, MODIFICATION 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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