The following data is part of a premarket notification filed by Covidien Llc with the FDA for Superdimension Triple-needle Cytology Brush.
| Device ID | K130357 |
| 510k Number | K130357 |
| Device Name: | SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH |
| Classification | Brush, Biopsy, Bronchoscope (non-rigid) |
| Applicant | Covidien LLC 161 CHESHIRE LANE STE 100 Minneapolis, MN 55441 |
| Contact | Kristen Swanson |
| Correspondent | Kristen Swanson Covidien LLC 161 CHESHIRE LANE STE 100 Minneapolis, MN 55441 |
| Product Code | BTG |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-13 |
| Decision Date | 2013-11-06 |
| Summary: | summary |