FDA 510(k)

FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

K-Number: K820790 · 1982-04-01

Decision Date1982-04-01

Product CodeFAM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1982-04-01 under 510(k) number K820790. The device is classified under product code FAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3?

FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 is a medical device that received FDA 510(k) clearance on 1982-04-01. The listed applicant is American Optical Corp.. The 510(k) number is K820790.

When did FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 receive FDA 510(k) clearance?

FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 received FDA 510(k) clearance on 1982-04-01, under 510(k) number K820790.

Who is the listed applicant for FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3?

The FDA 510(k) record lists American Optical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3?

The FDA product code for FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 is FAM.

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Other records listing American Optical Corp. as applicant

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Related Devices (Code: FAM)

K964131ENDOSCOPEAkos Biomedical, Inc.K970382VS-100 VIDEO SIGMOIDOSCOPEWelch Allyn, Inc.K964326VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.K964100VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100Vision-Sciences, Inc.K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPEVision-Sciences, Inc.K961567ES-3840, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.