510(k) K121186
K121186 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RADIAL JAW 4 PULMONARY BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on May 16, 2012. The device falls under product code BWH (Forceps, Biopsy, Bronchoscope (Non-Rigid)), a Class II device regulated under 21 CFR 874.4680. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2012
- Date Received
- April 18, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, 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).