FDA.reportPublic FDA data

510(k) K812965

Device
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
Applicant
AMERICAN OPTICAL CORP.
510(k) number
K812965
Product code
FAM  
Decision
Substantially Equivalent (SESE)
Decision date
1981-11-02
Date received
1981-10-22
Regulation
876.1500
Classification name
Sigmoidoscope And Accessories, Flexible/rigid
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964131ENDOSCOPEAkos Biomedical, Inc.1997-06-27
K970382VS-100 VIDEO SIGMOIDOSCOPEWelch Allyn, Inc.1997-04-17
K964326VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.1997-01-03
K964100VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100Vision-Sciences, Inc.1996-12-16
K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPEVision-Sciences, Inc.1996-11-21
K961567ES-3840, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.1996-06-24
K951577ES-3800, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.1996-03-21
K950429VIDEO SIGMOIDOSCOPEWelch Allyn, Inc.1995-08-01
K951576FS-34P2, FIBER SIGMOIDOSCOPEPentax Precision Instrument Corp.1995-06-29
K951573FS-38H, FIBER SIGMOIDOSCOPEPentax Precision Instrument Corp.1995-06-27
K951572FS-38X, FIBER SIGMOIDOSCOPEPentax Precision Instrument Corp.1995-06-27
K932843FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATHVision-Sciences, Inc.1994-02-14
K921690FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEMVision-Sciences, Inc.1992-10-28
K892000FLEXIBLE IMMERSIBLE SIGMOIDOSCOPESchott Fiber Optics, Inc.1989-04-25
K822765SIGMOIDOSCOPE, FLEXIBLEHarvard Laboratories1982-11-17

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases