GYRUS ACMI BICOAG HEMOSTASIS PROBE— 510(k) K123319
Substantially EquivalentOlympus Surgical Technologies America
FDA 510(k) clearance K123319 for GYRUS ACMI BICOAG HEMOSTASIS PROBE, Substantially Equivalent on 2012-12-14. Applicant: Olympus Surgical Technologies America. Device class: 2.
Clearance details
- Applicant
- Olympus Surgical Technologies America
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Southborough, MA, US
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Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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 →
Recalls naming K123319
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123319.
Data sourced from openFDA. This site is unofficial and independent of the FDA.