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FDA 510(k)

PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)

K-Number: K953561 · 1995-08-11

ApplicantOrigin Medsystems, Inc.
Decision Date1995-08-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PREPERITONEAL DISTENTION BALLOON SYSTEMS (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 1995-08-11 under 510(k) number K953561. 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 PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)?

PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K953561.

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

PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) received FDA 510(k) clearance on 1995-08-11, under 510(k) number K953561.

Who is the listed applicant for PREPERITONEAL DISTENTION BALLOON SYSTEMS (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 PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)?

The FDA product code for PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) is GCJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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