EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N— 510(k) K123317
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K123317 for EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N, Substantially Equivalent on 2012-12-11. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Center Valley, PA, US
Recent devices under product code FDS
view allMore clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K250993 — Single Use Cytology Brush V (BC-V600P-3010)
Adverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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.