HD CAMERA HEAD OTV-S7PROH-HD-L08E— 510(k) K083155
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K083155 for HD CAMERA HEAD OTV-S7PROH-HD-L08E, Substantially Equivalent on 2009-01-13. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code FET
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- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
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- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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.