FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
K Number: K252050
·
Decision Mar 20, 2026
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
81
Review Days
262
Basic Information
- Device Name
- Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K Number
- K252050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Medical Systems Corporation
- Date Received
- July 1, 2025
- Decision Date
- March 20, 2026
- Product Code
- EOB
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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|---|---|---|---|
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| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Oct 7, 2025 | Substantially Equivalent |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Oct 3, 2025 | Substantially Equivalent |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Sep 26, 2025 | Substantially Equivalent |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Sep 25, 2025 | Substantially Equivalent |