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FDA 510(k)

PSB PREPERITONEAL STRUCTURE BALLOON

K-Number: K942636 · 1994-07-01

ApplicantOrigin Medsystems, Inc.
Decision Date1994-07-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PSB PREPERITONEAL STRUCTURE 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 1994-07-01 under 510(k) number K942636. 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 PSB PREPERITONEAL STRUCTURE BALLOON?

PSB PREPERITONEAL STRUCTURE BALLOON is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K942636.

When did PSB PREPERITONEAL STRUCTURE BALLOON receive FDA 510(k) clearance?

PSB PREPERITONEAL STRUCTURE BALLOON received FDA 510(k) clearance on 1994-07-01, under 510(k) number K942636.

Who is the listed applicant for PSB PREPERITONEAL STRUCTURE 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 PSB PREPERITONEAL STRUCTURE BALLOON?

The FDA product code for PSB PREPERITONEAL STRUCTURE BALLOON is GCJ.

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Related Devices (Code: 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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