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FDA 510(k)

PENTAX Video Upper G.I. Scope EG34-i10

K-Number: K180292 · 2018-10-12

ApplicantPentax Medical of America, Inc.
Decision Date2018-10-12
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Video Upper G.I. Scope EG34-i10 is a medical device manufactured by Pentax Medical of America, Inc.. It received FDA 510(k) clearance on 2018-10-12 under approval number K180292. 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 PENTAX Video Upper G.I. Scope EG34-i10?

PENTAX Video Upper G.I. Scope EG34-i10 is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Pentax Medical of America, Inc.. The 510(k) number is K180292.

When was PENTAX Video Upper G.I. Scope EG34-i10 approved by the FDA?

PENTAX Video Upper G.I. Scope EG34-i10 received FDA 510(k) clearance on 2018-10-12, under approval number K180292.

What company makes PENTAX Video Upper G.I. Scope EG34-i10?

PENTAX Video Upper G.I. Scope EG34-i10 is manufactured by Pentax Medical of America, Inc..

What is the FDA product code for PENTAX Video Upper G.I. Scope EG34-i10?

The FDA product code for PENTAX Video Upper G.I. Scope EG34-i10 is FDS.

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Related Devices (Code: FDS)

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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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