Clarus Series 2100 Endoscope

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

510(k) Number

K923514 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K945296 Active Cleared 14 Jul 1995

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  FDA 510(k) K962255 Active Cleared 11 Sep 1996

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• Clarus Models 1230 and 1231 Laparo-Needle

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  FDA 510(k) K915725 Active Cleared 16 Nov 1992

See all devices from Clarus Medical Systems, Inc. →

• What is the Clarus Series 2100 Endoscope used for?

  The Clarus Series 2100 Endoscope is designed specifically for arthroscopic procedures in orthopedic surgery. It provides visual access to joint spaces, allowing surgeons to diagnose and treat conditions such as ligament injuries, cartilage defects, or synovial abnormalities. Its high-quality optics and ergonomic design enable precise manipulation within tight anatomical spaces, supporting minimally invasive techniques that minimize tissue trauma and accelerate patient recovery.

• Is the Clarus Series 2100 Endoscope reusable or single-use?

  The Clarus Series 2100 Endoscope is a reusable medical instrument. It is intended for use in sterile operating room environments and requires proper cleaning, sterilization, and maintenance as outlined by the manufacturer to ensure safety and functionality for repeated procedures.

• What regulatory pathway does the Clarus Series 2100 Endoscope follow?

  The device is regulated under the FDA 510(k) clearance process, specifically with clearance number K923514. It is classified under the HRX product code, indicating its use as an orthopedic arthroscopic device. The clearance was granted as substantially equivalent to a predicate device, reviewed by the Orthopedic (OR) Advisory Committee in 1994.

• How should the Clarus Series 2100 Endoscope be stored?

  While specific storage instructions are not detailed in the provided data, reusable endoscopes like the Clarus Series 2100 typically require storage in a clean, dry environment to prevent contamination. After sterilization, it should be stored in a dedicated case or protective packaging to maintain sterility and functionality until the next use. Always follow the manufacturer’s guidelines for proper handling and storage.

• Does the Clarus Series 2100 Endoscope have any MRI safety classification?

  The available data does not specify any MRI safety classification for the Clarus Series 2100 Endoscope. If MRI compatibility is required for your procedure, it is essential to verify this information directly with the manufacturer or consult their technical documentation.