Scholly Fiberoptic Gmbh

FDA Regulatory Profile

Scholly Fiberoptic Gmbh appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2364-2023, Class II) was initiated on June 23, 2023. Its most recent 510(k) clearance was granted on December 17, 2014.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2364-2023Class IIUroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument forJune 23, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K141366VIDEO BRONCHOSCOPE SYSTEMDecember 17, 2014
K133682SCHOELLY ARTHROSCOPEJune 2, 2014
K984556SCICAN CLASSICFebruary 9, 1999