MSS-28CS-301/701 NEEDLESCOPE— 510(k) K013759
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K013759 for MSS-28CS-301/701 NEEDLESCOPE, Substantially Equivalent on 2002-08-20. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code GWG
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- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Adverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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.