FLEXISCOPE IQ 101— 510(k) K992362
Substantially EquivalentSchoelly Fiberoptic GmbH
FDA 510(k) clearance K992362 for FLEXISCOPE IQ 101, Substantially Equivalent on 1999-08-05. Applicant: Schoelly Fiberoptic GmbH. Device class: 2.
Clearance details
- Applicant
- Schoelly Fiberoptic GmbH
- Product code
- Product 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
- Newton, MA, US
Recent devices under product code FET
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view all- K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- K221591 — Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
- K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
- K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
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.