Cleared Traditional

K072383 - HABIB ENDOBLATE

K072383 is an FDA 510(k) clearance for HABIB ENDOBLATE, manufactured by Emcision , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K072383 · Emcision , Ltd. · Gastroenterology & Urology device
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Nov 2007
Decision
97d
Days
Class 2
Risk

K072383 is an FDA 510(k) clearance for the HABIB ENDOBLATE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Emcision , Ltd. (London, Uk, GB). The FDA issued a Cleared decision on November 29, 2007 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Emcision , Ltd. devices

FDA 510(k) Submission Details - K072383

510(k) Number K072383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2007
Decision Date November 29, 2007
Days to Decision 97 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
34d faster than avg
Panel avg: 131d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 167
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K072383.
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K082464 · Medtronic, Inc. · Oct 2008
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
K080946 · Conmed Endoscopic Technologies, Inc. · May 2008
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
K061684 · Medi-Globe Corporation · Jun 2006
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
K052413 · Medtronic Vascular · Nov 2005
OMNI SPHINCTEROTOME
K052051 · Wilson-Cook Medical, Inc. · Aug 2005

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.