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GCP — Endoscope, Ac-Powered And Accessories Class II

FDA Device Classification

Classification Details

Product Code
GCP
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954614north eos industriesEOS BRAND DISPOSABLE PROCTOSCOPEApril 10, 1996
K896505porgesPORGES UNIVERSAL HANDLESJanuary 30, 1990
K896008medical dynamicsMODEL 6500 MERCURY ARC LIGHT SOURCEDecember 27, 1989
K862424endovationsSTEERABLE CATHETER SYSTEMSeptember 22, 1986
K860103endotherapeuticsMOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEFebruary 12, 1986
K843683reichert scientific instrumentsMODULAR FIBERSCOPE SYSTEMJanuary 18, 1985
K833859american endoscopyTAMPONADE BALLOON CUFFJanuary 3, 1984
K821999retechENDOSCOPIC SCLEROTHERAPY BALLOONAugust 27, 1982
K801247welch allynCCD ENDOSCOPE AND ATTACHMENTSJuly 28, 1980
K790071olympusENDOSCOPE AND ACCESSORIESApril 2, 1979
K771918propper mfg. coFIBEO OPTICS ILLUM. SYSTEMOctober 20, 1977
K771920propper mfg. coFIBER OPTICS PROCTOSCOPEOctober 20, 1977
K771919propper mfg. coFIBER OPTICS SIGMOIDOSCOPEOctober 20, 1977