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FDA 510(k)

FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES

K-Number: K974493 · 1998-03-31

ApplicantFiegert-Endotech Medizintechnik GmbH
Decision Date1998-03-31
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Fiegert-Endotech Medizintechnik GmbH. It received FDA 510(k) clearance on 1998-03-31 under 510(k) number K974493. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES?

FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES is a medical device that received FDA 510(k) clearance on 1998-03-31. The listed applicant is Fiegert-Endotech Medizintechnik GmbH. The 510(k) number is K974493.

When did FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES receive FDA 510(k) clearance?

FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES received FDA 510(k) clearance on 1998-03-31, under 510(k) number K974493.

Who is the listed applicant for FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES?

The FDA 510(k) record lists Fiegert-Endotech Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES?

The FDA product code for FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES is FDS.

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Related Devices (Code: FDS)

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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

Official Source

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

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