BWH · Class II · 21 CFR 874.4680

FDA Product Code BWH: Forceps, Biopsy, Bronchoscope (non-rigid)

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).

Leading manufacturers include Boston Scientific Corporation.

6
Total
6
Cleared
78d
Avg days
1984
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 14d recently vs 91d historically

FDA 510(k) Cleared Forceps, Biopsy, Bronchoscope (non-rigid) Devices (Product Code BWH)

6 devices
1–6 of 6
Cleared Sep 26, 2025
Radial Jaw 4 Pulmonary Biopsy Forceps
K252921
Boston Scientific Corporation
Anesthesiology · 14d

About Product Code BWH - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code BWH since 1984, with 6 receiving FDA clearance (average review time: 78 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under BWH have taken an average of 14 days to reach a decision - down from 91 days historically, suggesting improved FDA processing for this classification.

BWH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →