Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K881004 ↗

FDA Product Code

FCX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Keymed Office Couch

  Class II

  FDA 510(k) K854304 Active Cleared 12 Nov 1985

• Key-Med Fibrescope Disinfection Trolley

  Class II

  FDA 510(k) K810818 Active Cleared 8 Apr 1981

• Hi-Light 250 Light Source

  Class II

  FDA 510(k) K864801 Active Cleared 24 Dec 1986

• Ucs-2, Ultrasonic Cleaning Solution

  Class I

  FDA 510(k) K861147 Active Cleared 23 Jun 1986

• The Keymed Fiberscope Sterilization Case

  Class II

  FDA 510(k) K860528 Active Cleared 15 Jul 1986

• The Keymed Vari-Height Patient Couch

  Class II

  FDA 510(k) K853421 Active Cleared 19 Sep 1985

See all devices from Keymed, Inc. →

• What is the Olympus-Keymed ECR designed for?

  The Olympus-Keymed Endoscopic CO₂ Regulator, Model ECR, is specifically designed to deliver controlled carbon dioxide gas during endoscopic procedures. It facilitates insufflation—introducing gas into body cavities—to improve visualization and working space for diagnostic and therapeutic interventions in gastroenterology and urology. This ensures clearer views for clinicians performing procedures like colonoscopies or cystoscopies.

• Is the Olympus-Keymed ECR intended for single-use or reusable applications?

  The Olympus-Keymed ECR is designed for single-use in clinical settings. This design choice helps ensure patient safety by minimizing the risk of cross-contamination and reduces the need for sterilization between uses. Always follow the manufacturer’s instructions for proper handling and disposal.

• What types of endoscopic procedures can the ECR be used for?

  The ECR is primarily intended for procedures in gastroenterology and urology, where insufflation of CO₂ gas is required to expand body cavities. This includes diagnostic and therapeutic interventions such as colonoscopies, sigmoidoscopies, cystoscopies, and other endoscopic examinations where improved visualization is critical.

• How is the Olympus-Keymed ECR supplied, and what should be considered for storage?

  The Olympus-Keymed ECR is supplied as either a reusable or disposable unit, depending on the specific model variant. For single-use models, proper storage involves keeping the device in its original packaging until ready for use, ensuring it remains sterile and protected from contamination. Always adhere to the manufacturer’s guidelines for storage conditions to maintain device integrity and performance.

• What regulatory approvals does the Olympus-Keymed ECR hold?

  The Olympus-Keymed ECR holds a 510(k) clearance from the FDA, indicating it has been deemed substantially equivalent to a legally marketed device. This clearance is specific to its intended use as an automatic carbon-dioxide insufflator for endoscopic procedures. Always refer to the device’s labeling and the FDA database for the most current regulatory information.