Disposable Grasping Forceps FG-52D/FG-54D— 510(k) K250263
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K250263 for Disposable Grasping Forceps FG-52D/FG-54D, Substantially Equivalent on 2025-03-31. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code KTI
- 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
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Adverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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.