Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D— 510(k) K252050
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K252050 for Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D, Substantially Equivalent on 2026-03-20. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Summary
Olympus Medical Systems' Disposable Biopsy Forceps are filed under EOB, flexible or rigid nasopharyngoscopes. The name lists four models: FB-211D, FB-221D, FB-231D and FB-241D.
Class II, 21 CFR 874.4760. It was a Traditional 510(k), and Ear, Nose, and Throat is both the classification panel and the review panel.
Olympus Medical Systems filed from Tokyo, Japan. The decision came 262 calendar days after FDA received it (July 1, 2025 to March 20, 2026).
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Product code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code EOB
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- K260856 — Disposable Distal Attachment D-201-13404
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.