PENTAX Video Colonoscopes (EC Family)
K-Number: K181084 · 2019-01-18
Device Summary
Frequently Asked Questions
What is the PENTAX Video Colonoscopes (EC Family)?
PENTAX Video Colonoscopes (EC Family) is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Pentax of America, Inc.. The 510(k) number is K181084.
When did PENTAX Video Colonoscopes (EC Family) receive FDA 510(k) clearance?
PENTAX Video Colonoscopes (EC Family) received FDA 510(k) clearance on 2019-01-18, under 510(k) number K181084.
Who is the listed applicant for PENTAX Video Colonoscopes (EC Family)?
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 Video Colonoscopes (EC Family)?
The FDA product code for PENTAX Video Colonoscopes (EC Family) is FDF.
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.
Related Devices (Code: FDF)
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.
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.