Cytrellis Biosystems, Inc.

FDA Regulatory Profile

Cytrellis Biosystems, Inc. appears in FDA public data with 2 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2393-2023, Class II) was initiated on June 23, 2023. Its most recent 510(k) clearance was granted on October 30, 2025.

Summary

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

Recent Recalls

NumberClassProductDate
Z-2393-2023Class IIellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatJune 23, 2023
Z-1648-2023Class IICytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended forApril 7, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K252752ellacor System with Micro-Coring TechnologyOctober 30, 2025
K202517Cytrellis Dermal Micro-Coring SystemJuly 9, 2021