Product code GBI— General, Plastic Surgery

FDA has cleared 17 devices under product code GBI between 1977 and 1988, filed by 13 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19881 clearance
• 19874 clearances
• 19852 clearances
• 19843 clearances
• 19834 clearances
• 19821 clearance
• 19791 clearance
• 19771 clearance

• Delaware Prosthetics, Inc.3 clearances
• Coloplast Corp.3 clearances
• Virginia Hall, Inc.1 clearance
• Surgical Appliance Industries, Inc.1 clearance
• Sil-Med Corp.1 clearance
• Roseburg SA1 clearance
• Pacific Prosthetics, Inc.1 clearance
• Medeering, Ltd.1 clearance
• Ipos KG1 clearance
• Factor, Ii, Inc.1 clearance

• K880329 — FACTOR II PROSTHETIC SILICONE ELASTOMERFactor, Ii, Inc.·1988-06-01
• K874279 — AHH NATURAL BREAST FORMPacific Prosthetics, Inc.·1987-10-29
• K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARYRoseburg SA·1987-07-21
• K864785 — AMOENA BREAST FORMSColoplast Corp.·1987-01-08
• K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHTColoplast Corp.·1987-01-08
• K853822 — AMOENA BREAST FORMSColoplast Corp.·1985-09-30
• K851668 — PROSTHESIS OR SURGICAL PADSVirginia Hall, Inc.·1985-06-04
• K842765 — SILIMED BREAST FORMSil-Med Corp.·1984-08-17
• K841559 — CONFORMABeiersdorf, Inc.·1984-07-17
• K841171 — TRILICON BREASE PROSTHESIS DIFFERENTBaurs Krey Assoc., Inc.·1984-04-25
• K832151 — PDM SILOXANE PROSTHETIC ORBITDelaware Prosthetics, Inc.·1983-12-19
• K832152 — PDM SILOXANE PROSTHETIC EARDelaware Prosthetics, Inc.·1983-12-09
• K832153 — PDM SILOXANE PROSTHETIC NOSEDelaware Prosthetics, Inc.·1983-12-09
• K831831 — TRULIFE SILICONE BREAST FORMMedeering, Ltd.·1983-06-30
• K813416 — EXTERNAL BREAST PROSTHESISSurgical Appliance Industries, Inc.·1982-01-18
• K792372 — IPOS BREAST PROSTHESISIpos KG·1979-12-19
• K770359 — IMPLANTING OF POLYACRYLIC FIBERSAllan V. Marse·1977-04-08