Noblescope Neuroendoscope System & Accessories

FDA 510(k) K953554 · Nobles-Lai Engineering, Inc.

Substantially Equivalent

510(k) numberK953554

Submission

Device name
Noblescope Neuroendoscope System & Accessories
Applicant
Nobles-Lai Engineering, Inc.
Fountain Valley, CA, US
Received
July 28, 1995
Decision date
October 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWG – Endoscope, Neurological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1480
Specialty
Neurology

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K233391cCeLL - In vivoGWG · Traditional VPIX Medical, Inc.08/21/2024SE
K223615Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional Clarus Medical, LLC11/21/2023SE
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K230125Neuroblade SystemGWG · Traditional Clearmind Biomedical10/13/2023SE
K232159QEVO SystemGWG · Special Carl Zeiss Meditec, AG09/21/2023SE
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More from Hjy Smart Medical Device Co., Ltd.

510(k)DeviceDecision
K933345Nobles-Lai Endoscopic/LaparoscopicGCJ · Traditional 02/22/1994SE
K920026Nobles-Lai Imaging SystemFET · Traditional 07/28/1992SESK
K914457Disposable Optical ValvulotomeMGZ · Traditional 02/05/1992SE
K895688Nobles-Lai Engineering Infusion PumpDQI · Traditional 02/26/1990SE

Questions and answers

When was Noblescope Neuroendoscope System & Accessories cleared by the FDA?

Noblescope Neuroendoscope System & Accessories (K953554) received a 510(k) decision of Substantially Equivalent on October 18, 1995, 82 days after the submission was received.

What is the product code of K953554?

The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.