FDA Establishment Registration & Device Listing Our products are FDA registeredand compliant medical devices. Tissue Collection and Transport System forSFT-1000 SoftBiopsy®/SFT-2000 Soft-ECC®/SFT-2100 Soft-ECC-S® Registered Classifications for Forceps, Biopsy, Gynecological forSoftBiopsy®/ SpiraBrush ® Soft-ECC ® (Endocervical Curette)/Soft-ECC-S ® (Endocervical Curette) Registered Classifications for Brush, Biopsy, General & Plastic Surgery forSoft-Biopsy®