Cleared Traditional

K190669 - Endotics

K190669 is the FDA 510(k) clearance for Endotics by Era Endoscopy S.R.L.. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K190669 · Era Endoscopy S.R.L. · Gastroenterology & Urology device
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Jan 2020
Decision
294d
Days
Class 2
Risk

K190669 is an FDA 510(k) clearance for the Endotics. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Era Endoscopy S.R.L. (Peccioli, IT). The FDA issued a Cleared decision on January 3, 2020 after a review of 294 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 Era Endoscopy S.R.L. devices

Submission Details

510(k) Number K190669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2019
Decision Date January 03, 2020
Days to Decision 294 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
164d slower than avg
Panel avg: 130d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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 - FDF Colonoscope And Accessories, Flexible/rigid

All 66
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K190669.
G-EYE System
K202469 · Smart Medical Systems , Ltd. · Oct 2020
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K192793 · Olympus Medical Systems Corp. · Jul 2020
G-EYE System
K192588 · Smart Medical Systems , Ltd. · Apr 2020
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K192664 · Fujifilm Corporation · Nov 2019
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K191220 · Motus GI Medical Technologies , Ltd. · Jun 2019
FUJIFILM Endoscope Model EC-760S-V/L
K190649 · Fujifilm Corporation · May 2019