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FDA 510(k)

ENDOSCOPE

K-Number: K964131 · 1997-06-27

ApplicantAkos Biomedical, Inc.
Decision Date1997-06-27
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Akos Biomedical, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K964131. 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 ENDOSCOPE?

ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Akos Biomedical, Inc.. The 510(k) number is K964131.

When did ENDOSCOPE receive FDA 510(k) clearance?

ENDOSCOPE received FDA 510(k) clearance on 1997-06-27, under 510(k) number K964131.

Who is the listed applicant for ENDOSCOPE?

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

What is the FDA product code for ENDOSCOPE?

The FDA product code for ENDOSCOPE 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.

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.K951577ES-3800, 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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