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FDA 510(k)

OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM

K-Number: K963184 · 1996-12-31

ApplicantOlympus America, Inc.
Decision Date1996-12-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1996-12-31 under 510(k) number K963184. 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 OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM?

OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-31. The listed applicant is Olympus America, Inc.. The 510(k) number is K963184.

When did OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM receive FDA 510(k) clearance?

OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM received FDA 510(k) clearance on 1996-12-31, under 510(k) number K963184.

Who is the listed applicant for OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM?

The FDA product code for OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM is GCJ.

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Other records listing Olympus America, Inc. as applicant

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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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