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FDA 510(k)

ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA

K-Number: K946002 · 1995-01-05

ApplicantOrigin Medsystems, Inc.
Decision Date1995-01-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA 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 1995-01-05 under 510(k) number K946002. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA?

ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA is a medical device that received FDA 510(k) clearance on 1995-01-05. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K946002.

When did ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA receive FDA 510(k) clearance?

ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA received FDA 510(k) clearance on 1995-01-05, under 510(k) number K946002.

Who is the listed applicant for ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA?

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 ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA?

The FDA product code for ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA is GEX. This falls under the Gastroenterology category.

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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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