CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
FDA 510(k) K142934 · Covidien
Submission
- Device name
- CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
- Applicant
- Covidien
Plymouth, MN, US - Received
- October 9, 2014
- Decision date
- June 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved cleared by the FDA?
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (K142934) received a 510(k) decision of Substantially Equivalent on June 17, 2015, 251 days after the submission was received.
What is the product code of K142934?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.