Endoscope, Neurological

FDA product code GWG · Class 2 · Neurology

501

Registered devices

283

Adverse events

Recalls

510(k) clearances

Devices with this code

Date	Firm	Reason
2026-01-15	Aesculap Inc	There is the potential for the length of the trocar shaft to be too long.
2025-02-06	Integra LifeSciences Corp.	Possibility for the obturator to break (separate).
2024-06-07	Integra LifeSciences Corp.	Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
2023-07-20	Aesculap Implant Systems LLC	Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the
2019-08-27	Karl Storz Endoscopy	During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick
2019-08-27	Karl Storz Endoscopy	During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick
2019-08-27	Karl Storz Endoscopy	During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick
2019-02-20	Karl Storz Endoscopy	The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
2017-03-07	Aesculap Implant Systems LLC	Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of t
2011-12-16	Geomed Medizin-Technik Gmbh & Co.	The product may fracture during surgical procedures.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.