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FDA 510(k)

MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE

K-Number: K812965 · 1981-11-02

ApplicantAmerican Optical Corp.
Decision Date1981-11-02
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE 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 1981-11-02 under 510(k) number K812965. 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 MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE?

MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is American Optical Corp.. The 510(k) number is K812965.

When did MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE receive FDA 510(k) clearance?

MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812965.

Who is the listed applicant for MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE?

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 MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE?

The FDA product code for MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE is FAM.

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Other records listing American Optical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950881PHACO TIPK950880AOI UNIVERSAL ULTRASONIC HANDPIECEK931354P4000 PHACOEMULSIFIERK931358AORP4000 REUSABLE PAKK931357AOD4000 DISPOSABLE PAKK820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

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Related Devices (Code: FAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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