FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROBIOLOGY SPECIMEN BRUSH
K Number: K820771
·
Decision May 3, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
46
Review Days
41
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Basic Information
- Device Name
- MICROBIOLOGY SPECIMEN BRUSH
- K Number
- K820771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Mill-Rose Laboratory
- Date Received
- March 23, 1982
- Decision Date
- May 3, 1982
- Product Code
- BTG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTG), ordered by most recent decision date.
Disposable Cytology Brush BC-202D/203D Series
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Pulmonary Cytology Brush
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FDA Class 2
·Ear, Nose, Throat
Single Use Cytology Brush BC-205D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Mill-Rose Laboratory
| K Number | Device Name | ||
|---|---|---|---|
| K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent |
| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | May 23, 1997 | Substantially Equivalent |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | Jul 29, 1996 | Substantially Equivalent |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | Apr 29, 1996 | Substantially Equivalent |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 22, 1995 | Substantially Equivalent |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | Dec 18, 1995 | Substantially Equivalent |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | Nov 27, 1995 | Substantially Equivalent |
| K951051 | RITE-BITE BIOPSY FORCEPS | Mar 24, 1995 | Substantially Equivalent |
| K951048 | RITE-BITE BIOPSY FORCEPS | Mar 15, 1995 | Substantially Equivalent |