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S-Line Bipolar Resectoscopes and Bipolar Electrodes

by Richard Wolf Medical Instruments Corp.

510(k) K062720

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK062720 Date22 Mar 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2246-2021 FDA Class II initiated 25 Jun 2021

    Product labeled as Cutting Electrode may contain BIVAP electrode.

    • Terminated Z-0145-2014 FDA Class II initiated 18 Sep 2013

    Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

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  • Withdrawn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
FJL
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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