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FDA 510(k)

PENTAX EPK-I5020 VIDEO PROCESSOR

K-Number: K113873 · 2012-06-22

ApplicantPentax of America, Inc.
Decision Date2012-06-22
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX EPK-I5020 VIDEO PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2012-06-22 under 510(k) number K113873. 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 PENTAX EPK-I5020 VIDEO PROCESSOR?

PENTAX EPK-I5020 VIDEO PROCESSOR is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Pentax of America, Inc.. The 510(k) number is K113873.

When did PENTAX EPK-I5020 VIDEO PROCESSOR receive FDA 510(k) clearance?

PENTAX EPK-I5020 VIDEO PROCESSOR received FDA 510(k) clearance on 2012-06-22, under 510(k) number K113873.

Who is the listed applicant for PENTAX EPK-I5020 VIDEO PROCESSOR?

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

What is the FDA product code for PENTAX EPK-I5020 VIDEO PROCESSOR?

The FDA product code for PENTAX EPK-I5020 VIDEO PROCESSOR is FET.

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Other records listing Pentax of America, Inc. 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.

K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)K251127PENTAX Medical Video Processor (EPK-i8020c)K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

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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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