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FDA 510(k)

IEC MEDSIGHT AND MEDBRIGHT

K-Number: K080809 · 2008-08-11

ApplicantInnovative Endoscopy Components, LLC
Decision Date2008-08-11
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IEC MEDSIGHT AND MEDBRIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Endoscopy Components, LLC. It received FDA 510(k) clearance on 2008-08-11 under 510(k) number K080809. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IEC MEDSIGHT AND MEDBRIGHT?

IEC MEDSIGHT AND MEDBRIGHT is a medical device that received FDA 510(k) clearance on 2008-08-11. The listed applicant is Innovative Endoscopy Components, LLC. The 510(k) number is K080809.

When did IEC MEDSIGHT AND MEDBRIGHT receive FDA 510(k) clearance?

IEC MEDSIGHT AND MEDBRIGHT received FDA 510(k) clearance on 2008-08-11, under 510(k) number K080809.

Who is the listed applicant for IEC MEDSIGHT AND MEDBRIGHT?

The FDA 510(k) record lists Innovative Endoscopy Components, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IEC MEDSIGHT AND MEDBRIGHT?

The FDA product code for IEC MEDSIGHT AND MEDBRIGHT is FET.

Related Clinical Trials

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.

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Other records listing Innovative Endoscopy Components, LLC 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.

K062707RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPEK992983BAHO AUTOCLAVABLE CYSTOSCOPE

Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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