OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1— 510(k) K011484
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K011484 for OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1, Substantially Equivalent on 2001-08-10. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code FBK
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view all- K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.