Greenwald Control-Tip Cystoscopic Electrode

FDA 510(k) K933173 · Greenwald Surgical Co., Inc.

Substantially Equivalent

510(k) numberK933173

Submission

Device name
Greenwald Control-Tip Cystoscopic Electrode
Applicant
Greenwald Surgical Co., Inc.
Lake Station, IN, US
Received
June 29, 1993
Decision date
April 1, 1994
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
K933175Greenwald Control Tip Ureteroscopic ElectrodeFAS · Traditional 04/01/1994SE
K933174Greenwald Flexible Endoscopic ElectrodeFAS · Traditional 04/01/1994SE
K780137Clamp, Incontinence, BaumruckerFHA · Traditional 04/28/1978SE

Questions and answers

When was Greenwald Control-Tip Cystoscopic Electrode cleared by the FDA?

Greenwald Control-Tip Cystoscopic Electrode (K933173) received a 510(k) decision of Substantially Equivalent on April 1, 1994, 276 days after the submission was received.

What is the product code of K933173?

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