Cleared Traditional

K122565 - ARC ENDOCUFF

K122565 is an FDA 510(k) clearance for ARC ENDOCUFF, manufactured by Boddingtons Plastics, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K122565 · Boddingtons Plastics, Ltd. · Gastroenterology & Urology device
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Sep 2012
Decision
13d
Days
Class 2
Risk

K122565 is an FDA 510(k) clearance for the ARC ENDOCUFF. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Boddingtons Plastics, Ltd. (Tonbridge, Kent, GB). The FDA issued a Cleared decision on September 4, 2012 after a review of 13 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boddingtons Plastics, Ltd. devices

FDA 510(k) Submission Details - K122565

510(k) Number K122565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date September 04, 2012
Days to Decision 13 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 131d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Bsi Healthcare

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 82
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K122565.
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · Boston Scientific Corp · Dec 2012
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
K122270 · Apollo Endosurgery, Inc. · Sep 2012
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
K120126 · Barosense, Inc. · Sep 2012
ENDOFLIP ECD
K110531 · Crospon, Ltd. · Oct 2011
RE-TRACE URETERAL ACCESS SHEATH
K102485 · Coloplast A/S · Oct 2010
ENTEROSCOPY OVERTUBE, MODEL 00712140
K100081 · United States Endoscopy Group, Inc. · Apr 2010

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.