Codman Steerable Endoscope (Cat.# 83-1340)

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K920979 ↗

FDA Product Code

GCQ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Orbit Galaxy G2 Microcoil Delivery System

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  FDA 510(k) K761096 Active Cleared 30 Nov 1976

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See all devices from Codman & Shurtleff, Inc. →

• What is the Codman Steerable Endoscope (Cat.# 83-1340) used for?

  The Codman Steerable Endoscope (Cat.# 83-1340) is a flexible endoscope intended for internal visualization and manipulation of body cavities, hollow organs, and canals. It supports diagnostic and therapeutic procedures in gastroenterology and urology, such as minimally invasive examinations and interventions. Its design allows for precise navigation and access during procedures, reducing the need for more invasive techniques.

• Is the Codman Steerable Endoscope (Cat.# 83-1340) single-use or reusable?

  This endoscope is designed as a reusable medical device. It must undergo sterilization and maintenance following the manufacturer’s guidelines to ensure safety and functionality for repeated clinical use. Proper cleaning and sterilization protocols are critical to prevent contamination and maintain device integrity.

• What regulatory approval does the Codman Steerable Endoscope (Cat.# 83-1340) hold?

  The Codman Steerable Endoscope (Cat.# 83-1340) has been cleared by the FDA under the 510(k) pathway, specifically with clearance number K920979. This classification confirms it is substantially equivalent to a legally marketed device and is authorized for use in gastroenterology and urology procedures in the United States.

• Where can the Codman Steerable Endoscope (Cat.# 83-1340) be used?

  This device is intended for use in controlled clinical settings such as operating rooms, endoscopy suites, and procedural rooms. Its flexible design and steerable capabilities make it suitable for navigating complex anatomical pathways during diagnostic and therapeutic interventions in specialized medical fields like gastroenterology and urology.

• How should the Codman Steerable Endoscope (Cat.# 83-1340) be stored?

  While the provided data does not specify storage instructions, reusable medical devices like this endoscope generally require storage in a clean, dry environment to prevent damage or contamination. The manufacturer’s guidelines should be followed for proper storage, handling, and maintenance to ensure the device remains functional and safe for reuse.