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FDA 510(k)

ROLLER ELECTRODE

K-Number: K951863 · 1995-08-24

ApplicantOlympus America, Inc.
Decision Date1995-08-24
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROLLER ELECTRODE 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 1995-08-24 under 510(k) number K951863. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLLER ELECTRODE?

ROLLER ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Olympus America, Inc.. The 510(k) number is K951863.

When did ROLLER ELECTRODE receive FDA 510(k) clearance?

ROLLER ELECTRODE received FDA 510(k) clearance on 1995-08-24, under 510(k) number K951863.

Who is the listed applicant for ROLLER ELECTRODE?

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 ROLLER ELECTRODE?

The FDA product code for ROLLER ELECTRODE is FAS.

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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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