Olympus Subfascial Endoscopic Perforating Vein Surgery (seps) System, Its Assoc…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973232

Identifiers

510(k) Number: K973232 FDA 510(k)
FDA Product Code: GCJ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Olympus Subfascial Endoscopic Perforating Vein Surgery (seps) System, Its Assoc… by Olympus Winter & Ibe GmbH — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K973232	Class II	Active

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Manufacturer

Manufacturer: Olympus Winter & Ibe GmbH

Sources (1)

FDA 510(k) K973232 24 fields · synced Jun 19, 2026