The following data is part of a premarket notification filed by Covidien Llc with the FDA for Gencut Core Biopsy System.
| Device ID | K142839 |
| 510k Number | K142839 |
| Device Name: | GenCut Core Biopsy System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Covidien LLC 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Contact | Jenny Jiang |
| Correspondent | Jenny Jiang Covidien LLC 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521539716 | K142839 | 000 |
| 10884521809550 | K142839 | 000 |