510(k) K130357
K130357 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on November 6, 2013. The device falls under product code BTG (Brush, Biopsy, Bronchoscope (Non-Rigid)), a Class II device regulated under 21 CFR 874.4680. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2013
- Date Received
- February 13, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Biopsy, Bronchoscope (Non-Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4680
- Review Panel
- EN
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).