Precision Optics Endoscope Adapter

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

510(k) Number

K903459 ↗

FDA Product Code

FET

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Precision Optics Image Coupler

  Class II

  FDA 510(k) K903458 Active Cleared 19 Oct 1990

• PI808 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K820178 Active Cleared 4 Mar 1982

• Precision Optics Corporation Laparoscope

  Class II

  FDA 510(k) K911744 Active Cleared 26 Jul 1991

• P2020-8-0 Beam Limiting Device

  Class II

  FDA 510(k) K914184 Active Cleared 27 Nov 1991

• PHF20 20 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K935580 Active Cleared 16 Mar 1994

• P1806 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K792225 Active Cleared 20 Dec 1979

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• What specialties is the Precision Optics Endoscope Adapter primarily designed for, and how does it improve imaging during procedures?

  The Precision Optics Endoscope Adapter is designed for use in gastroenterology and urology, as indicated by its advisory committee classification (GU). It enhances imaging by interfacing between endoscope optics and video capture systems, improving visualization for diagnostic and therapeutic interventions in these specialties. This ensures clearer, more precise imaging during procedures like colonoscopies or cystoscopies.

• Is the Precision Optics Endoscope Adapter intended for single-use or reusable applications, and what should clinicians consider when deciding?

  The device is intended for either single-use or reusable applications, depending on manufacturer guidelines. Clinicians should follow the specific reprocessing instructions provided by Precise Optics to ensure safety and sterility, particularly since it is used in sterile environments. Reuse requires proper cleaning, sterilization, and maintenance to prevent contamination or degradation of performance.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical settings?

  The Precision Optics Endoscope Adapter received FDA clearance under the 510(k) pathway (K903459), classified as substantially equivalent to a predicate device. This means it underwent a traditional review by the FDA, ensuring compliance with 21 CFR 876.1500 standards for endoscopic video imaging systems. Clinicians can rely on this clearance as evidence of its safety and effectiveness for intended use in gastroenterology and urology procedures.

• Are there specific storage requirements for the Precision Optics Endoscope Adapter, and how should it be handled to maintain performance?

  While the provided data does not specify exact storage conditions, the device is intended for use in sterile environments, suggesting it should be stored in a clean, dry place away from direct sunlight or extreme temperatures. If reusable, it must be properly cleaned, sterilized, and stored according to manufacturer instructions to prevent damage or contamination before reuse.

• What types of endoscopes is this adapter compatible with, and how do I confirm compatibility with my existing equipment?

  The adapter is designed for compatibility with endoscopic video imaging systems in gastroenterology and urology, as outlined in its regulatory classification (FET product code). To confirm compatibility with your specific endoscope model, consult Precise Optics’ documentation or contact their support team, as adapter fit and function may vary depending on the brand and type of endoscope in use.