Product code GCP— Gastroenterology, Urology

FDA has cleared 13 devices under product code GCP between 1977 and 1996, filed by 11 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.

• 19961 clearance
• 19901 clearance
• 19891 clearance
• 19862 clearances
• 19851 clearance
• 19841 clearance
• 19821 clearance
• 19801 clearance
• 19791 clearance
• 19773 clearances

• Propper Mfg. Co., Inc.3 clearances
• Welch Allyn, Inc.1 clearance
• Retech1 clearance
• Reichert Scientific Instruments1 clearance
• Porges Corp.1 clearance
• Olympus Corp.1 clearance
• North Eos Industries, Inc.1 clearance
• Medical Dynamics, Inc.1 clearance
• Endovations1 clearance
• Endotherapeutics1 clearance

• K954614 — EOS BRAND DISPOSABLE PROCTOSCOPENorth Eos Industries, Inc.·1996-04-10
• K896505 — PORGES UNIVERSAL HANDLESPorges Corp.·1990-01-30
• K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.·1989-12-27
• K862424 — STEERABLE CATHETER SYSTEMEndovations·1986-09-22
• K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEEndotherapeutics·1986-02-12
• K843683 — MODULAR FIBERSCOPE SYSTEMReichert Scientific Instruments·1985-01-18
• K833859 — TAMPONADE BALLOON CUFFAmerican Endoscopy, Inc.·1984-01-03
• K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOONRetech·1982-08-27
• K801247 — CCD ENDOSCOPE AND ATTACHMENTSWelch Allyn, Inc.·1980-07-28
• K790071 — ENDOSCOPE AND ACCESSORIESOlympus Corp.·1979-04-02
• K771918 — FIBEO OPTICS ILLUM. SYSTEMPropper Mfg. Co., Inc.·1977-10-20
• K771919 — FIBER OPTICS SIGMOIDOSCOPEPropper Mfg. Co., Inc.·1977-10-20
• K771920 — FIBER OPTICS PROCTOSCOPEPropper Mfg. Co., Inc.·1977-10-20