Clarus Spinepen Model 2126

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K955598 ↗

FDA Product Code

GWG

Device Class

Class II

Regulation

21 CFR Part 882.1480

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K945296 Active Cleared 14 Jul 1995

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  FDA 510(k) K962255 Active Cleared 11 Sep 1996

• Percscope Model 2600

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  FDA 510(k) K974579 Active Cleared 18 Feb 1998

• Clarus Series 2100 Endoscope

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• Clarus Cholangiogram Catheter Kit

  Class I

  FDA 510(k) K925742 Active Cleared 1 Jun 1993

• Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)

  Class II

  FDA 510(k) K971584 Active Cleared 23 May 1997

See all devices from Clarus Medical Systems, Inc. →

• What is the Clarus Spinepen Model 2126 used for?

  The Clarus Spinepen Model 2126 is an endoscope designed for neurological procedures, as indicated by its classification under regulation number 882.1480 and its assignment to the Neurology medical specialty. It was found substantially equivalent to a predicate device, meaning it performs the same neurological endoscopic functions as previously cleared devices.

• How was the Clarus Spinepen Model 2126 authorized for market release?

  The device received FDA 510(k) clearance under submission number K955598 on February 6, 1996, through a traditional review process. This authorization pathway confirms it is substantially equivalent to a legally marketed predicate device, allowing it to be sold in the United States for its intended neurological endoscopic use.

• What regulatory classification applies to the Clarus Spinepen Model 2126?

  The Clarus Spinepen Model 2126 is classified as a Class II medical device under FDA regulation number 882.1480, which governs neurological endoscopes. This classification reflects its moderate risk level and the general and special controls required to ensure its safety and effectiveness in neurological applications.