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Greenwald Control-Tip Cystoscopic Electrode

by Greenwald Surgical Co., Inc.

510(k) K933173

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933173 Date1 Apr 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FAS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Greenwald Control-Tip Cystoscopic Electrode is an active, electrosurgical electrode designed for urological procedures. It is classified as a Class II device and is intended for use in conjunction with a cystoscope to facilitate tissue ablation or coagulation during endoscopic interventions in the urinary bladder or urethra.

This device is supplied as a single-use, sterile electrode and is regulated under FDA 510(k) clearance (K933173) with a traditional review pathway. It is intended for use in controlled clinical settings, such as operating rooms or procedural suites, and must be handled in accordance with standard electrosurgical safety protocols. The electrode is manufactured in the United States and adheres to regulatory requirements outlined under 876.4300.

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