Cleared Traditional

K180292 - PENTAX Video Upper G.I. Scope EG34-i10

K180292 is the FDA 510(k) clearance for PENTAX Video Upper G.I. Scope EG34-i10 by Pentax Medical of America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K180292 · Pentax Medical of America, Inc. · Gastroenterology & Urology device
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Oct 2018
Decision
253d
Days
Class 2
Risk

K180292 is an FDA 510(k) clearance for the PENTAX Video Upper G.I. Scope EG34-i10. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Pentax Medical of America, Inc. (Montvale, US). The FDA issued a Cleared decision on October 12, 2018 after a review of 253 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentax Medical of America, Inc. devices

Submission Details

510(k) Number K180292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2018
Decision Date October 12, 2018
Days to Decision 253 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 130d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 56
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