GenCut Core Biopsy System
FDA 510(k) K142839 · Covidien, LLC
510(k) numberK142839
Submission
- Device name
- GenCut Core Biopsy System
- Applicant
- Covidien, LLC
Plymouth, MN, US - Received
- September 30, 2014
- Decision date
- April 29, 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 GenCut Core Biopsy System cleared by the FDA?
GenCut Core Biopsy System (K142839) received a 510(k) decision of Substantially Equivalent on April 29, 2015, 211 days after the submission was received.
What is the product code of K142839?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.