Single Use Aspiration Needle NA-U200H— 510(k) K151738
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K151738 for Single Use Aspiration Needle NA-U200H, Substantially Equivalent on 2015-11-20. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
Recent devices under product code FCG
view allMore clearances from Olympus Medical Systems Corp.
view all- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more
- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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.