EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

FDA 510(k) K211030 · Boston Scientific Corporation

Substantially Equivalent

510(k) numberK211030

Submission

Device name
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
Applicant
Boston Scientific Corporation
Marlboro, MA, US
Received
April 6, 2021
Decision date
August 9, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EOQ – Bronchoscope (Flexible Or Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4680
Specialty
Ear, Nose, Throat

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…

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Questions and answers

When was EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor cleared by the FDA?

EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor (K211030) received a 510(k) decision of Substantially Equivalent on August 9, 2021, 125 days after the submission was received.

What is the product code of K211030?

The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.