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FDA 510(k)

SIGMOIDOSCOPE, FLEXIBLE

K-Number: K822765 · 1982-11-17

ApplicantHarvard Laboratories
Decision Date1982-11-17
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIGMOIDOSCOPE, FLEXIBLE is the device name listed in this FDA 510(k) record. The listed applicant is Harvard Laboratories. It received FDA 510(k) clearance on 1982-11-17 under 510(k) number K822765. 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, FLEXIBLE?

SIGMOIDOSCOPE, FLEXIBLE is a medical device that received FDA 510(k) clearance on 1982-11-17. The listed applicant is Harvard Laboratories. The 510(k) number is K822765.

When did SIGMOIDOSCOPE, FLEXIBLE receive FDA 510(k) clearance?

SIGMOIDOSCOPE, FLEXIBLE received FDA 510(k) clearance on 1982-11-17, under 510(k) number K822765.

Who is the listed applicant for SIGMOIDOSCOPE, FLEXIBLE?

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

What is the FDA product code for SIGMOIDOSCOPE, FLEXIBLE?

The FDA product code for SIGMOIDOSCOPE, FLEXIBLE is FAM.

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Other records listing Harvard Laboratories 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.

K810573TUBE FEEDING SETK810574SUCTION COLLECTION BOTTLE, DISPOSABLEK800877ANESTHESIA EXTENSION TUBESK800878SECONDARY I.V. TUBING SETSK800879CLEAR PLASTIC CONNECTING TUBESK800880PLASTIC TUBING ADAPTERS 5-IN-1-

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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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