FDA 510(k)

OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES

K-Number: K970797 · 1997-05-28

Decision Date1997-05-28

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES 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 1997-05-28 under 510(k) number K970797. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES?

OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Olympus America, Inc.. The 510(k) number is K970797.

When did OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1997-05-28, under 510(k) number K970797.

Who is the listed applicant for OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES?

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 PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES?

The FDA product code for OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES is GEI.

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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.