REUSABLE GUIDE— 510(k) K141334
Substantially EquivalentKoelis
FDA 510(k) clearance K141334 for REUSABLE GUIDE, Substantially Equivalent on 2014-07-11. Applicant: Koelis. Device class: 2.
Clearance details
- Applicant
- Koelis
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Tronche, FR
Recent devices under product code ITX
view allMore clearances from Koelis
view all- K180970 — Disposable guides KDNG00
- K171040 — Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
- K170521 — TRINITY/3D PROSTATE SUITE
- K160357 — TRINITY
- K131448 — 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.