ClearanceBrief
Panels › Neurology › Product code GWG · Class 2

Endoscope, Neurological

Regulation 882.1480

4510(k)s in 12 months (95 all time)
1recalls in 12 months (22 all time)
18recalls that name a 510(k)
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Top companies in GWG

DateFirm and productCodeLinked 510(k)
Mar 2, 2026Aesculap Inc
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/
Open, Classified
GWGK983365
Mar 6, 2025Integra LifeSciences Corp.
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Open, Classified
GWGK201840
Jul 11, 2024Integra LifeSciences Corp.
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Open, Classified
GWGK232618
Sep 6, 2023Aesculap Implant Systems LLC
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Open, Classified
GWGK983365
Aug 27, 2019Karl Storz Endoscopy
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Open, Classified
GWGK002788
Aug 27, 2019Karl Storz Endoscopy
Karl Storz, Model # 11161C2, Flexible Neuroscope
Open, Classified
GWGK002788
K991069
Aug 27, 2019Karl Storz Endoscopy
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Open, Classified
GWGK002788
Feb 20, 2019Karl Storz Endoscopy
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Terminated
GWGK002788
Mar 20, 2017Aesculap Implant Systems LLC
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treat
Terminated
GWGK983365
May 11, 2012Mitaka USA, Inc.
Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
Terminated
GWGK984355
Mar 8, 2012Visionsense, Ltd.
Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE: Model Numbers 172-0032, 172-0044, 172-0070,
Terminated
GWGK081102
Feb 19, 2012Geomed Medizin-Technik Gmbh & Co.
ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm Systems with a holding power of up to 50
Terminated
GWGK052745
Oct 21, 2005Remington Medical Inc.
Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized.
Terminated
GWGNone listed
Oct 21, 2005Remington Medical Inc.
Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized
Terminated
GWGNone listed
Oct 21, 2005Remington Medical Inc.
Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.
Terminated
GWGNone listed
Aug 10, 2005Medtronic Neurosurgery
Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
Terminated
GWGK990333
Aug 10, 2005Medtronic Neurosurgery
Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F
Terminated
GWGK990333
Mar 12, 2005Medtronic Neurosurgery
MurphyScope, Curved, Mallaeble, Catalog # 2125-163
Terminated
GWGK010341
Mar 12, 2005Medtronic Neurosurgery
MurphyScope, Bayonet, Malleable, Catalog # 2121-157
Terminated
GWGK010341
Jul 20, 2004Medtronic Neurosurgery
Channel Neuroendoscope, Standard Resolution, 13 cm, Catalog No. 2232-003.
Terminated
GWGNone listed
Jul 20, 2004Medtronic Neurosurgery
Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001
Terminated
GWGK945633
Jul 15, 2003EBI, L.P.
EBI VueCath Endoscopic Spinal System
Terminated
GWGK010179
K023233 +2

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