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FDA 510(k)

SIGMOIDOSCOPE/ DISPOSABLE

K-Number: K761180 · 1977-01-05

ApplicantSmithkline Diagnostics, Inc.
Decision Date1977-01-05
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIGMOIDOSCOPE/ DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-01-05 under 510(k) number K761180. 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 SIGMOIDOSCOPE/ DISPOSABLE?

SIGMOIDOSCOPE/ DISPOSABLE is a medical device that received FDA 510(k) clearance on 1977-01-05. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K761180.

When did SIGMOIDOSCOPE/ DISPOSABLE receive FDA 510(k) clearance?

SIGMOIDOSCOPE/ DISPOSABLE received FDA 510(k) clearance on 1977-01-05, under 510(k) number K761180.

Who is the listed applicant for SIGMOIDOSCOPE/ DISPOSABLE?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMOIDOSCOPE/ DISPOSABLE?

The FDA product code for SIGMOIDOSCOPE/ DISPOSABLE is FAM.

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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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