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FDA 510(k)

OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT

K-Number: K973232 · 1997-11-21

ApplicantOlympus Winter & Ibe GmbH
Decision Date1997-11-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973232. 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 SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT?

OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K973232.

When did OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT receive FDA 510(k) clearance?

OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973232.

Who is the listed applicant for OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT?

The FDA product code for OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT is 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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