Cleared Special

K191067 - Arc Endocuff Glide AEG110 & AEG120

K191067 is an FDA 510(k) clearance for Arc Endocuff Glide AEG110 & AEG120, manufactured by Boddingtons Plastics, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 38-day FDA review.

K191067 · Boddingtons Plastics, Ltd. · Gastroenterology & Urology device
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May 2019
Decision
38d
Days
Class 2
Risk

K191067 is an FDA 510(k) clearance for the Arc Endocuff Glide AEG110 & AEG120. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Boddingtons Plastics, Ltd. (Tonbridge, GB). The FDA issued a Cleared decision on May 30, 2019 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191067

510(k) Number K191067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2019
Decision Date May 30, 2019
Days to Decision 38 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 131d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 103
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K191067.
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K191067 · Arc Endocuff Glide AEG110 & AEG120
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