The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Radial Jaw 4 Pulmonary Biopsy Forceps.
| Device ID | K121186 |
| 510k Number | K121186 |
| Device Name: | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Bronchoscope (non-rigid) |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Corrie Gooding |
| Correspondent | Corrie Gooding BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | BWH |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-18 |
| Decision Date | 2012-05-16 |
| Summary: | summary |