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Resectoscope Electro Cautery Cutting Loop

by American Urologicals, Inc.

510(k) K943879

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 NumberK943879 Date7 Feb 1995ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

A resectoscope electro cautery cutting loop is an active urological electrode device used in electrosurgical procedures. It is designed for cutting and coagulating tissue during transurethral resection of bladder tumors (TURBT) and similar urological interventions.

The device is supplied as a reusable instrument, requires sterilization prior to use, and is intended for use in clinical settings such as hospitals or ambulatory surgical centers. It received FDA 510(k) clearance (K943879) on February 7, 1995, and is classified as a Class II medical device under regulation number 876.4300 with product code FAS.

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP used for?

    It is an active urological electrode device designed for cutting and coagulating tissue during electrosurgical procedures, specifically transurethral resection of bladder tumors (TURBT) and similar urological interventions, as it enables precise tissue removal and hemostasis in clinical settings.

  • Is the RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP reusable or single-use?

    The device is supplied as a reusable instrument, meaning it can be used multiple times after proper cleaning and sterilization, which is necessary because it is intended for repeated clinical use in hospitals or ambulatory surgical centers following validated reprocessing protocols.

  • How is the RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP supplied and prepared for use?

    It is supplied non-sterile and requires sterilization prior to each use, as indicated by its reusable nature and intended use in clinical settings, ensuring it meets infection control standards before being applied in urological electrosurgical procedures.