K121186 is an FDA 510(k) clearance for the RADIAL JAW 4 PULMONARY BIOPSY FORCEPS. This device is classified as a Forceps, Biopsy, Bronchoscope (non-rigid) (Class II - Special Controls, product code BWH).
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on May 16, 2012, 28 days after receiving the submission on April 18, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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)..
| 510(k) Number | K121186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2012 |
| Decision Date | May 16, 2012 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | BWH — Forceps, Biopsy, Bronchoscope (non-rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | 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). |