FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Single Use Cytology Brush BC-205D
K Number: K190293
·
Decision Aug 2, 2019
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
102
Review Days
172
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Basic Information
- Device Name
- Single Use Cytology Brush BC-205D
- K Number
- K190293
- 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
- Olympus Medical Systems Corp.
- Date Received
- February 11, 2019
- Decision Date
- August 2, 2019
- Product Code
- BTG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- 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
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pulmonary Cytology Brush
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROBIOLOGY SPECIMEN BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Olympus Medical Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | May 21, 2026 | Substantially Equivalent |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Apr 23, 2026 | Substantially Equivalent |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Mar 6, 2026 | Substantially Equivalent |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Feb 22, 2026 | Substantially Equivalent |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Nov 12, 2025 | Substantially Equivalent |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Oct 24, 2025 | Substantially Equivalent |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Oct 17, 2025 | Substantially Equivalent |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Sep 19, 2025 | Substantially Equivalent |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Jun 23, 2025 | Substantially Equivalent |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Jun 5, 2025 | Substantially Equivalent |