Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors

FDA 510(k) K971881 · Comeg Endoscopy

Substantially Equivalent

510(k) numberK971881

Submission

Device name
Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors
Applicant
Comeg Endoscopy
Aurora, CO, US
Received
May 20, 1997
Decision date
August 12, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FJL – Resectoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

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K221893KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional Karl Storz Endoscopy America, Inc.03/17/2023SE
K230205Veloxion SystemFJL · Special Corinth Medtech, Inc.02/24/2023SE
K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…FJL · Special Corinth Medtech, Inc.06/13/2019SE
K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…FJL · Traditional Corinth Medtech, Inc.03/15/2019SE
K162979Veloxion SystemFJL · Traditional Corinth Medtech, Inc.03/24/2017SE
K102663AED ResectoscopeFJL · Traditional National Advanced Endoscopy Devices, Inc.12/30/2010SE
K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesFJL · Traditional Richard Wolf Medical Instruments Corp.03/22/2007SE
K042523Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, AccessoriesFJL · Traditional Richard Wolf Medical Instruments Corp.03/18/2005SE
K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207FJL · Traditional Richard Wolf Medical Instruments Corp.08/19/2004SE

More from Richard Wolf Medical Instruments Corp.

510(k)DeviceDecision
K970764Comeg Endoscopy Resectoscope AccessoriesOCX · Traditional 04/22/1997SE
K970489Comeg Endoscopy Grasping ForcepsFFL · Traditional 03/19/1997SE

Questions and answers

When was Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors cleared by the FDA?

Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors (K971881) received a 510(k) decision of Substantially Equivalent on August 12, 1997, 84 days after the submission was received.

What is the product code of K971881?

The FDA product code is FJL – Resectoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.