Endolap Resectoscope Roller Electrode

FDA 510(k) K974515 · Endolap, Inc.

Substantially Equivalent

510(k) numberK974515

Submission

Device name
Endolap Resectoscope Roller Electrode
Applicant
Endolap, Inc.
Orlando, FL, US
Received
December 2, 1997
Decision date
December 22, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FAS – Electrode, Electrosurgical, Active, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

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More from Olympus Winter & Ibe GmbH

510(k)DeviceDecision
K974516Endolap Resectoscope Cutting Loop ElectrodeFAS · Traditional 12/22/1997SE
K950243Titan Insufflation NeedleGCJ · Traditional 04/06/1995SE
K950219Endolap Insufflator Tubing SetHIF · Traditional 03/23/1995SE
K933492Esys SystemHET · Traditional 03/25/1994SE

Questions and answers

When was Endolap Resectoscope Roller Electrode cleared by the FDA?

Endolap Resectoscope Roller Electrode (K974515) received a 510(k) decision of Substantially Equivalent on December 22, 1997, 20 days after the submission was received.

What is the product code of K974515?

The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.