Product code FCI— Gastroenterology, Urology

FDA has cleared 5 devices under product code FCI between 1983 and 1990, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19901 clearance
• 19891 clearance
• 19881 clearance
• 19851 clearance
• 19831 clearance

• National-Standard Co.1 clearance
• Integrated Display Technology, Ltd.1 clearance
• Diasonics, Inc.1 clearance
• August C. Stiefel Research Institute, Inc.1 clearance
• Advanced Diagnostic Medical Systems, Inc.1 clearance

• K895885 — AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTINGNational-Standard Co.·1990-02-09
• K894627 — BT-338N ELECTRONIC CLINICAL THERMOMETERIntegrated Display Technology, Ltd.·1989-10-23
• K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBEAdvanced Diagnostic Medical Systems, Inc.·1988-03-02
• K853104 — DISPOSABLE, STERILE BIOPSY PUNCHAugust C. Stiefel Research Institute, Inc.·1985-10-04
• K831317 — BIOPSY ATTACHMENTDiasonics, Inc.·1983-05-18