Single Use Biopsy Forceps FB-456D— 510(k) K200397
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K200397 for Single Use Biopsy Forceps FB-456D, Substantially Equivalent on 2020-04-24. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
Recent devices under product code EOQ
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- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
- K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700) +2 more
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.