FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REUSABLE BRONCHIAL BIOPSY FORCEPS
K Number: K022398
·
Decision Oct 11, 2002
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
5
Applicant Total
26
Review Days
80
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Basic Information
- Device Name
- REUSABLE BRONCHIAL BIOPSY FORCEPS
- K Number
- K022398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ballard Medical Products
- Date Received
- July 23, 2002
- Decision Date
- October 11, 2002
- Product Code
- BWH
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWH), ordered by most recent decision date.
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RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
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UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | Mar 11, 1998 | Substantially Equivalent |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |
| K923487 | BAL CATH | Jul 30, 1993 | Unknown |