BWHClass II
Forceps, Biopsy, Bronchoscope (Non-Rigid)
21 CFR 874.4680 / Ear, Nose, Throat
BWH is the FDA product code for Forceps, Biopsy, Bronchoscope (Non-Rigid), a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "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)". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- BWH
- Device name
- Forceps, Biopsy, Bronchoscope (Non-Rigid)
- FDA 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).
- Regulation
- 21 CFR 874.4680
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code BWH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1993 | 1 |
| 2002 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code BWH| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 3 |
| Ballard Medical Products | 1 |
| Rush Hampton Industries | 1 |
| Wiltek Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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