Forceps, Biopsy, Bronchoscope (Non-Rigid)
The Forceps, Biopsy, Bronchoscope (Non-Rigid) are cup-like jaw instruments passed through a flexible bronchoscope to obtain tissue specimens from bronchial lesions or the lung periphery for histopathological diagnosis. They are classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BWH, regulated under 21 CFR 874.4680 in the Ear, Nose, and Throat specialty. This device is eligible for third-party review. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission, as required by 82 FR 26807.
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Basic Information
- Product Code
- BWH
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Sep 26, 2025 | Substantially Equivalent | Boston Scientific Corporation |
| K121186 | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | May 16, 2012 | Substantially Equivalent | Boston Scientific Corp |
| K102336 | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE | Jan 24, 2011 | Substantially Equivalent | Boston Scientific Corporation |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Oct 11, 2002 | Substantially Equivalent | Ballard Medical Products |
| K930419 | WILTEK BIOPSY FORCEPS | Jun 01, 1993 | Substantially Equivalent | Wiltek Medical, Inc. |
| K843282 | UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC | Oct 22, 1984 | Substantially Equivalent | Rush Hampton Industries |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.