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FAM — Sigmoidoscope And Accessories, Flexible/Rigid Class II

FDA Device Classification

Classification Details

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

Definition

to examine and perform procedures within the sigmoid (descending) colon

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964131akos biomedicalENDOSCOPEJune 27, 1997
K970382welch allynVS-100 VIDEO SIGMOIDOSCOPEApril 17, 1997
K964326vision-sciencesVISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATHJanuary 3, 1997
K964100vision-sciencesVISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIDecember 16, 1996
K963344vision-sciencesDISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDNovember 21, 1996
K961567pentax precision instrumentES-3840, VIDEO SIGMOIDOSCOPEJune 24, 1996
K951577pentax precision instrumentES-3800, VIDEO SIGMOIDOSCOPEMarch 21, 1996
K950429welch allynVIDEO SIGMOIDOSCOPEAugust 1, 1995
K951576pentax precision instrumentFS-34P2, FIBER SIGMOIDOSCOPEJune 29, 1995
K951572pentax precision instrumentFS-38X, FIBER SIGMOIDOSCOPEJune 27, 1995
K951573pentax precision instrumentFS-38H, FIBER SIGMOIDOSCOPEJune 27, 1995
K932843vision-sciencesFLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATHFebruary 14, 1994
K921690vision-sciencesFLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEMOctober 28, 1992
K892000schott fiber opticsFLEXIBLE IMMERSIBLE SIGMOIDOSCOPEApril 25, 1989
K822765harvard laboratoriesSIGMOIDOSCOPE, FLEXIBLENovember 17, 1982
K820790american opticalFLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3April 1, 1982
K812965american opticalMODEL SC-6, FLEXIBLE SIAMOIDOSCOPENovember 2, 1981
K792341pentax precision instrumentPENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34December 10, 1979
K792314icl scientificRID SYSTEMS - ALPH-1-ACID GLYCOPROTEINDecember 6, 1979
K790610welch allynSIGMOIDOSCOPE TIPLESSApril 23, 1979