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Bronchoscope Accessory, NSN 6515-00-315-2200

by Delta Industries, Inc.

510(k) K911922

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911922 Date29 Jul 1991ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a bronchoscope accessory, classified under FDA product code EOQ and intended for use in ear, nose, and throat procedures. Bronchoscopes are rigid or flexible endoscopes used to visualize and access the airways, and accessories like this one are designed to enhance functionality during bronchoscopy, such as suctioning, irrigation, or instrument passage. The accessory is engineered to interface with bronchoscope systems, ensuring compatibility and ease of use in clinical settings.

The Bronchoscope Accessory, NSN 6515-00-315-2200, is supplied as a reusable device and is regulated under FDA 510(k) clearance (K911922) with a decision of Substantially Equivalent. It is intended for use in sterile environments and must be properly cleaned, disinfected, and maintained between procedures to prevent cross-contamination. The device falls under FDA Class II and is governed by regulation number 874.4680. No specific MRI safety information is provided, and storage conditions should adhere to manufacturer guidelines for reusable medical instruments.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Bronchoscope Accessory NSN 6515-00-315-2200 used for?

    This bronchoscope accessory is designed to enhance bronchoscopy procedures by enabling suctioning, irrigation, or passage of instruments through the airway. It interfaces with bronchoscope systems to improve functionality during ear, nose, and throat (ENT) interventions, ensuring compatibility and ease of use in clinical settings.

  • Is the Bronchoscope Accessory NSN 6515-00-315-2200 single-use or reusable?

    The device is explicitly supplied as a reusable accessory. To maintain safety and prevent cross-contamination, it must be thoroughly cleaned, disinfected, and properly maintained between uses in sterile environments, following manufacturer guidelines for reusable medical instruments.

  • What regulatory clearance does the Bronchoscope Accessory NSN 6515-00-315-2200 hold?

    This accessory holds FDA 510(k) clearance under the reference number K911922, with a decision of 'Substantially Equivalent' to a predicate device. It is classified under FDA product code EOQ and falls under FDA Class II, governed by regulation number 874.4680.

  • What storage conditions should be followed for this bronchoscope accessory?

    While specific MRI safety information is not provided, the accessory should be stored according to the manufacturer’s guidelines for reusable medical instruments. Proper storage conditions help preserve functionality and sterility, ensuring readiness for clinical use when needed.

  • How does this accessory ensure compatibility with bronchoscope systems?

    The accessory is engineered specifically to interface with bronchoscope systems, ensuring seamless integration for tasks like suctioning, irrigation, or instrument passage. This design compatibility reduces the risk of procedural disruptions and enhances overall usability in clinical settings.