ClearanceBrief
Company · DE

Schoelly Fiberoptic GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2024. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
EOBNasopharyngoscope (Flexible Or Rigid)3
GCJLaparoscope, General & Plastic Surgery3
HIHHysteroscope (And Accessories)2
EIAUnit, Operative Dental1
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology1
FGAKit, Nephroscope1
HETLaparoscope, Gynecologic (And Accessories)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 20, 2024K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic s
Schoelly Fiberoptic GmbH, DE
GCJ
Feb 23, 2023K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
Schoelly Fiberoptic GmbH, DE
GCJ
Mar 12, 2021K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
Schoelly Fiberoptic GmbH, DE
HET
Oct 8, 2020K201970Schoelly Cystoscopes/Hysteroscopes and Accessories
Schoelly Fiberoptic GmbH, DE
HIH
Feb 9, 2016K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Schoelly Fiberoptic GmbH, DE
FGA
Mar 9, 2015K150158Schoelly Cystoscopes/Hysteroscopes and Accessories
Schoelly Fiberoptic GmbH, DE
HIH
Mar 4, 2015K143673CMOS Video Nasopharyngoscope System
Schoelly Fiberoptic GmbH, DE
EOB
Jan 27, 2015K142249SCHOELLY SINUSCOPE
Schoelly Fiberoptic GmbH, DE
EOB
Dec 5, 2014K143221Schoelly Laparoscope
Schoelly Fiberoptic GmbH, DE
GCJ
Apr 9, 2014K132009CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
Schoelly Fiberoptic GmbH
EOB
Aug 5, 1999K992362FLEXISCOPE IQ 101
Schoelly Fiberoptic GmbH
FET
Mar 29, 1999K984641FLEXISCOPE OPTOMODUL
Schoelly Fiberoptic GmbH
EIA

Latest recalls

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