Product code FZI— General, Plastic Surgery

FDA has cleared 5 devices under product code FZI between 1978 and 1991, filed by 4 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.

• 19912 clearances
• 19851 clearance
• 19782 clearances

• Edward Weck, Inc.2 clearances
• E.M. Adams1 clearance
• Central Georgia Ancillary Health Systems1 clearance
• Alcon Laboratories1 clearance

• K911132 — MULTIPLE, SURGICAL DRAPE PACKCentral Georgia Ancillary Health Systems·1991-05-06
• K910468 — STERILE DISPOSABLE DRAPE(S)E.M. Adams·1991-03-21
• K854159 — ELLIPTI-PUNCHAlcon Laboratories·1985-11-15
• K772394 — KALRN FACE-LIFE SCISSORSEdward Weck, Inc.·1978-03-09
• K772395 — DAVIS RHYTIDECTOMYEdward Weck, Inc.·1978-03-09